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Oracle® Health Sciences Clinical Development Analytics User's Guide
Release 3.2
E74647-01
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A Dashboards and Analyses

This section describes predefined dashboards and analyses delivered with Oracle Health Sciences Clinical Development Analytics (OHSCDA):

Oracle Health Sciences Clinical Development Analytics Dashboards

OHSCDA is delivered with seven dashboards. These dashboards can be accessed by users with a specific job responsibility and security privileges. Each dashboard has tabbed pages that displays reports.

OHSCDA includes the following dashboards:

Log on to OHSCDA, and select the dashboard you want to view.

Note:

If Oracle Clinical (OC) and InForm are not your source systems for OHSCDA, you must disable the data management dashboards (Data Manager - EDC and Data Manager - Paper).

  1. Log on to OHSCDA as a user with the administrator role.

  2. Click Catalog.

  3. Under Folders on the left pane, navigate to Shared Folders > OCDA > Dashboards > Data Manager - EDC.

  4. Under Tasks on the left pane, click Permissions.

    The Permissions dialog box appears.

  5. Select No Access from the drop-down list of the relevant account.

  6. Click OK.

  7. Perform steps 3 through 6 for the Data Manager - Paper dashboard.

CRA Dashboard

This is the basic dashboard for a Clinical Research Associate (CRA). It provides some initial reports for a CRA, and is intended as starting point for an implementation.

This dashboard can be accessed by Study Manager, Executive, Region Manager, and CRA. It provides reports related to site status and performance, subject recruitment and retention, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

  • CRA: Lists All CRAs within a Study (required)

  • Study: Lists all Studies.

CRA Dashboard Pages

This dashboard includes the following tabbed pages:

CRA Overview Page

Displays reports on which monitoring reports require completion or approval, as well as lists study-sites with key information and an indicator of study-site health.

The CRA Overview page includes the following reports:

Study-Site Milestones Page

Displays a report that lists study-sites with key milestone dates.

The Study-Site Milestones page includes the following page-specific prompts:

  • Study-Site ID #: Lists Sites within a Study, by site number.

  • Study-Site Status: Lists the Statuses of a Study-Site.

  • Study Region: Lists the Regions for a Study.

  • Principal Investigator: Lists the Principal Investigators for a Study-Site.

The Study-Site Milestones page includes the following reports:

Initiating & Recruiting Sites Page

Displays reports on uninitiated sites and documents, and initiated sites and recruitment.

The Initiating and Recruiting Sites page includes the following page-specific prompts:

  • Study-Site ID #: Lists Sites within a Study, by site number.

  • Study-Site Status: Lists the Statuses of a Study-Site.

  • Study Region: Lists the Regions for a Study.

  • Principal Investigator: Lists the Principal Investigators for a Study-Site.

The Initiating and Recruiting page includes the following reports:

Monitoring Metrics Page

Displays reports on cycle times for monitoring report completion and approval, as well as site visit frequency.

The Monitoring Metrics page includes the following page-specific prompts:

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Monitoring Metrics page includes the following reports:

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

Site Document List Page

Displays a report that lists document tracking information for site documents.

The Site Document List page includes the following page-specific prompts:

  • Study-Site ID #: Lists Sites within a Study, by site number.

  • Study-Site Status: Lists the Statuses of a Study-Site.

  • Study Region: Lists the Regions for a Study.

  • Principal Investigator: Lists the Principal Investigators for a Study-Site.

  • Activity Type: Lists the Activity Types for documents.

  • Document Name: Lists the Document Names.

  • Document Sent Date Between: Date range for Document Sent Date.

  • Document Received Date Between: Date range for Document Received Date.

  • Document Expiration Date Between: Date range for Document Expiration Date.

The Site Document List page includes the following report:

eCRF Workload Page

Displays reports on the current workload.

This eCRF Workload page includes the following reports:

Performance Page

Displays reports on key cycle times.

The Performance page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

Map of Study Sites Page

The Map of Study Sites page includes the following report:

Data Manager - EDC Dashboard

This dashboard is the Data Management dashboard for EDC studies. It can be accessed by Data Manager, Study Manager, and Region Manager. It provides numerous reports and charts to monitor performance of EDC studies.

The Data Manager - EDC dashboard includes these prompts, which are common to all its pages:

  • Study: Lists Studies within a Program.

  • Study Site: Lists Sites within a Study.

The eCRF Workload, Discrepancy Workload, Quality, Key Rates and Performance pages also include the following prompts:

  • Sponsor: Lists the name of the Sponsor companies for which this study is being conducted.

  • Program: Lists the name of the Programs that owns the Study.

Data Manager - EDC Dashboard Pages

This dashboard includes the following tabbed pages:

Home Page

Displays key study based reports.

The Home page includes the following page-specific prompts:

  • Metric is in Bottom: Supplemental prompt for those reports that might display a long list of metrics.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Home page includes the following reports:

eCRF Workload Page

Displays reports on the current workload.

The eCRF Workload page includes the following reports:

Quality Page

Displays reports on the key quality indicators.

The Quality page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Quality page includes the following reports:

Key Rates Page

Displays reports on the key performance rates.

The Key Rates page includes the following page-specific prompts:

  • Metric is in Bottom: Supplemental prompt for those reports that might display a long list of metrics.

The Key Rates page includes the following reports:

Performance Page

Displays reports on key cycle times.

The Performance page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

Study Discrepancies Page

Displays reports on the key study based discrepancy indicators.

The Study Discrepancies page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Study Discrepancies page includes the following reports:

Study Processing Summary Page

Displays reports on eCRFs waiting processing summary.

The Study Processing Summary page includes the following page-specific prompts:

  • Subject ID: Lists IDs for the subject about whom the data were collected.

The Study Processing Summary page includes the following reports:

Study Processing Detail Page

Displays reports on eCRFs waiting processing detail.

The Study Processing Detail page includes the following reports:

Data Manager - Paper Dashboard

This dashboard is Data Management dashboard for paper studies. It can be accessed by Data Manager, Study Manager, and Region Manager. It provides numerous reports and charts to monitor performance of Paper studies.

This dashboard includes the following prompts, which are common to all its pages:

  • Study: Lists Studies within a Program.

  • Study Site: Lists Sites within a Study.

The Page Workload, Discrepancy Workload, Quality and Performance pages also include the following prompts:

  • Sponsor: Lists the name of the Sponsor companies for which this study is being conducted.

  • Program: Lists the name of the Programs that owns the Study.

Data Manager - Paper Dashboard Pages

This dashboard includes the following tabbed pages:

Home Page

Displays key study based reports.

The Home page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Home page includes the following reports:

Page Workload Page

Displays reports on the current workload.

The Page Workload page includes the following reports:

Quality Page

Displays reports on the key quality indicators.

The Quality page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Quality page includes the following reports:

Performance Page

Displays reports on the key performance rates.

The Performance page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Performance page includes the following reports:

Study Processing Summary Page

Displays reports on paper CRFs waiting processing summary.

The Study Processing Summary page includes the following page-specific prompts:

  • Subject ID: Lists IDs for the subject about whom the data were collected.

The Study Processing Summary page includes the following reports:

Study Processing Detail Page

Displays reports on paper CRFs waiting processing detail.

The Study Processing Detail page includes the following reports:

Executive Dashboard

This dashboard can be accessed by an Executive. This dashboard includes the following prompts, which are common to all its pages:

  • Program: Lists the name of the Programs that owns the Study.

  • Therapeutic Area

  • Study-phase

  • Protocol Approved Date

  • Clinical Study Report Date

Executive Dashboard Pages

This dashboard includes the following tabbed pages:

Overview Page

Displays report links with the following attributes:

  • Section Title - Study Performance Reports

  • Show Section Header - True

  • Show Section Title - True

  • Collapsible - False

The Overview page includes the following page-specific prompt:

  • Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Overview page includes the following reports:

Site Performance Summary Page

The Site Performance Summary page includes the following reports:

Study List Page

The Study List page includes the following page-specific prompts:

  • Study: Lists Studies within a Program.

  • Study Status: Lists Study Status for a Study.

  • Study Manager: List Study Manager for a Study.

The Study List page includes the following report:

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following report:

Study-Site Map Page

The Study-Site Map page includes the following report:

Region Manager Dashboard

This dashboard can be accessed by Study Manager, Executive, and Region Manager. This dashboard includes the following prompts, which are common to all its pages:

  • Study-Region Manager

  • Region Name

  • Program

  • Therapeutic Area

  • Protocol Approved Date

  • Clinical Study Report Date

Region Manager Dashboard Pages

This dashboard includes the following tabbed pages:

Monitoring Metrics Page

The Monitoring Metrics page includes the following page-specific prompts:

  • Site Visit Type: Lists types of site visits.

  • Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Monitoring Metrics page includes the following reports:

Initiating and Recruiting Study Regions Page

The Initiating and Recruiting Study Regions page includes the following reports:

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

Map of Study Sites Page

The Map of Study Sites page includes the following report:

Study Manager Dashboard

This dashboard can be accessed by Study Manager, Executive, and Region Manager. It provides reports related to study status and performance, subject recruitment and retention, site monitoring metrics, and investigator performance.

This dashboard includes the following prompts, which are common to all its pages:

  • Program: Lists the name of the Programs that owns the Study.

  • Study: Lists Studies within a Program.

  • Study Manager: Lists Study Manager for a Study.

  • Study Status: Lists Study Status for a Study.

Study Manager Dashboard Pages

This dashboard includes the following tabbed pages:

Study Manager Overview Page

Displays report links with the following attributes:

  • Section Title - Study Performance Reports

  • Show Section Header - True

  • Show Section Title - True

  • Collapsible - False

The Study Manager Overview page includes the following reports:

Initiating & Recruiting Studies Page

Displays reports on studies actively initiating and actively recruiting.

The Initiating & Recruiting Studies page includes the following reports:

Monitoring Metrics Page

Displays reports on monitoring reports awaiting approval, outstanding follow up items, and monitoring report completion and approval cycle times.

The Monitoring Metrics page includes the following page-specific prompts:

Year/Month Between: Supplemental prompt for those reports that include charts displaying data over time.

Site Visit Type: Lists types of site visits.

The Monitoring Metrics page includes the following reports:

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also, displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

Map of Study Sites Page

The Map of Study Sites page includes the following report:

Study Overview Dashboard

This dashboard can be accessed by any user. It provides reports related to study status and performance, site performance within the study, subject recruitment and retention, investigator performance, site performance, study region performance, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

  • Program: Lists the name of the Programs that owns the Study.

  • Study: Lists Studies within a Program.

  • Study Status: Lists Study Status for a Study.

  • Study Manager: Lists Study Manager for a Study.

Study Overview Dashboard Pages

This dashboard includes the following tabbed pages:

Study Overview Page

Displays reports that contain identifying information for a study as well has high level overviews of milestones and subject recruitment and retention.

The Study Overview page includes the following page-specific prompts:

  • Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Study Overview page includes the following reports:

Study-Site Milestones Page

Displays a report that lists all sites for the study and which milestones have been met.

The Study-Site Milestones page includes the following page-specific prompts:

  • Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

  • Study-Site ID#: List of Study-Sites for a Study.

The Study-Site Milestones page includes the following reports:

Screening Overview Page

Displays reports on a study's progress toward screening, including screen failure reason analysis.

The Screening Overview page includes the following page-specific prompt:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Screening Overview page includes the following reports:

Recruitment Overview Page

Displays reports on a study's progress toward recruitment, including recruitment over time.

The Recruitment Overview page includes the following page-specific prompts:

  • Study Region: Supplemental prompt for those reports that don't make sense unless run for a small set of study-sites or study regions.

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Recruitment Overview page includes the following reports:

Retention Overview Page

Displays reports on a study's retention pattern, including withdrawn reason analysis and retention vs. enrollment over time.

The Retention Overview page includes the following page-specific prompts:

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Retention Overview page includes the following reports:

Top Investigators Page

Displays reports showing the top N investigators by % site enrollment completed or total enrollment. Also, displays top investigators' contribution compared to all other investigators.

The Top Investigators page includes the following page-specific prompts:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

Non Performing Investigators Page

Displays reports that list initiated sites / investigators enrolling no subjects, or only one subject.

The Non Performing Investigators page includes the following reports:

Site Performance Page

Displays reports on the distribution of top performing and non performing investigators.

The Site Performance page includes the following reports:

Site Region Performance Page

Displays reports on the distribution of enrollment across study regions, and by site for each study region.

The Study Region Performance page includes the following reports:

Monitoring Metrics Page

Displays reports on patterns in site visit length and monthly enrollment, as well as lists outstanding follow up items for the study.

The Monitoring Metrics page includes the following page-specific prompts:

  • Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Site Visit Type: Lists types of site visits.

The Monitoring Metrics page includes the following reports:

Site Document List Page

Displays a report that lists document tracking information for study documents.

The Site Document List page includes the following report:

Site Document Metrics Page

Displays reports on cycle times for site document collection.

The Site Document Metrics page includes the following page-specific prompt:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Site Document Metrics page includes the following reports:

Study Team Page

The Study Team page includes the following report:

Map of Study Sites Page

The Map of Study Sites page includes the following report:

Risk Profile Page

Provides a snapshot of multiple study level risk indictors used in Risk Based Monitoring (RBM). It also includes a map of Study-Sites by risk indicator.

The Risk Profile page includes the following page-specific sections:

  • Subject Recruitment and Discontinuation

  • Issue Management

  • Essential Documents

  • Risk Indicators by Study-Site

  • Data Quality

The Risk Profile page includes the following reports:

Protocol Deviations Page

Provides a snapshot of both Study-Site and Subject Protocol Deviations, broken out by Category and by Site.

The Protocol Deviations page includes the following reports:

Study-Region Overview Dashboard

This dashboard can be accessed by any user. This dashboard includes the following prompts, which are common to all its pages:

  • Study

  • Therapeutic Area

  • Program

  • Region

  • Study-Region

  • Study-Region Manager

  • Study Status

  • Study-Region Status

Study-Region Overview Dashboard Pages

This dashboard includes the following tabbed pages:

Recruitment Overview Page

The Recruitment Overview page includes the following page-specific prompt:

  • Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Recruitment Overview page includes the following reports:

Retention Overview Page

The Retention Overview page includes the following page-specific prompt:

  • Year Between: Supplemental prompt for those reports that include charts displaying data over year.

The Retention Overview page includes the following reports:

Top Investigators Page

The Top Investigators page includes the following page-specific prompt:

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Top Investigators page includes the following reports:

Non Performing Investigators Page

The Non Performing Investigators page includes the following reports:

Monitoring Reports and Follow Up Items Page

The Monitoring Reports and Follow Up Items page includes the following page-specific prompts:

  • Site Visit Type: Lists types of site visits.

  • Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Follow Up Item Type: Lists types of follow up item.

The Monitoring Reports and Follow Up Items page includes the following report:

Study-Region Team Page

The Study-Region Team page includes the following page-specific prompts:

  • Active: Lists active status for team members.

  • Role: Lists roles for team members.

  • Start Date: Supplemental prompt for those reports that include charts displaying data over a period of time.

  • End Date: Supplemental prompt for those reports that include charts displaying data over a period of time.

The Study-Region Team page includes the following report:

Region Document List Page

The Region Document List page includes the following page-specific prompts:

  • Activity Type: Lists the Activity Types for documents.

  • Document Name: Lists the Document Names.

  • Document Sent Date Between: Date range for Document Sent Date.

  • Document Received Date Between: Date range for Document Received Date.

  • Document Expiration Date Between: Date range for Document Expiration Date.

The Region Document List page includes the following report:

Map of Study-Sites Page

The Map of Study-Sites page includes the following report:

Study-Site Overview Dashboard

This dashboard can be accessed by any user. It provides reports related to site status and performance, subject recruitment and retention within the study-site, site monitoring, and document tracking.

This dashboard includes the following prompts, which are common to all its pages:

  • Program: Lists the name of the Programs that owns the Study.

  • Study: Lists Studies within a Program.

  • Study Region: Lists Regions within a Study.

  • Study-Site ID#: Lists Study-Sites within a Study.

  • Principal Investigator: Lists Principal Investigator for a Study-Site.

  • Study-Site Status: Lists Study Status for a Study.

Study-Site Overview Dashboard Pages

This dashboard includes the following tabbed pages:

Screening & Recruitment Overview Page

Displays reports on a study-site's progress toward screening and enrollment, including screen failure reason analysis and screening or recruitment over time.

The Screening & Recruitment Overview page includes the following page-specific prompt:

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

The Screening & Recruitment Overview page includes the following reports:

Retention Overview Page

Displays reports on a study-site's retention pattern, including withdrawn reason analysis and retention vs. enrollment over time.

The Retention Overview page includes the following page-specific prompts:

  • Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Retention Overview page includes the following reports:

Monitoring Metrics Page

Displays reports on site visit length trends, subject enrollment over time, and distribution of follow up items by type.

The Monitoring Metrics page includes the following page-specific prompts:

  • Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Site Visit Type: Lists types of site visits.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Monitoring Metrics page includes the following reports:

Study-Site Team Page

Displays a report that lists team members assigned to the study-site.

The Study-Site Team page includes the following page-specific prompts:

  • Role: Lists roles for team members.

  • Team Member Active: Select the check box for whether or not team member is active.

  • Start Date Between: Supplemental prompt for those reports that include charts displaying data over a period of time.

  • End Date Between: Supplemental prompt for those reports that include charts displaying data over a period of time.

The Study-Site Team page includes the following report:

Site Document List Page

Displays a report that lists document tracking information for site documents.

The Site Document List page includes the following page-specific prompts:

  • Activity Type: Lists the Activity Types for documents.

  • Document Name: Lists the Document Names.

  • Document Sent Date Between: Date range for Document Sent Date.

  • Document Received Date Between: Date range for Document Received Date.

  • Document Expiration Date Between: Date range for Document Expiration Date

The Site Document List page includes the following report:

Site Document Metrics Page

Displays reports on cycle times for site document collection.

The Site Document Metrics page includes the following page-specific prompt:

  • Activity Type: Lists the Activity Types for documents.

  • Document Name: Lists the Document Names.

  • Metric is in Top: Supplemental prompt for those reports that might display a long list of metrics.

The Site Document Metrics page includes the following reports:

Visit Reports & Follow Up Items Page

Displays reports that contain identifying information for a study as well has high level overviews of milestones and subject recruitment and retention.

The Visit Reports & Follow Up Items page includes the following page-specific prompts:

  • Site Visit Start Date Between: Supplemental prompt for those reports that include charts displaying data over time.

  • Site Visit Type: Lists types of site visits.

The Visit Reports & Follow Up Items page includes the following reports:

Risk Profile Page

Provides a snapshot of multiple study-site level risk indictors used in Risk Based Monitoring (RBM).

The Risk Profile page includes the following page-specific sections:

  • Subject Recruitment and Discontinuation

  • Issue Management

  • Essential Documents

  • Data Quality

The Risk Profile page includes the following reports:

Protocol Deviations Page

Provides a snapshot of both Study-Site and Subject Protocol Deviations, broken out by Category.

The Protocol Deviations page includes the following reports:

Index Dashboard

This dashboard can be accessed by any user. It provides users with an at a glance listing of all dashboards and analyses and allows users to navigate directly to specific dashboard pages or analyses.

Index Dashboard Pages

This dashboard includes the following tabbed pages:

Dashboard & Dashboard Page Index Page

Displays a listing of all dashboards and dashboard pages.

Dashboard Page & Analysis Index Page

Displays a listing of all dashboard pages and their analyses including analyses that do not appear directly on dashboard pages but can only be accessed by navigating from other analyses.

Oracle Health Sciences Clinical Development Analytics Analyses

Note:

If InForm is your source system, you must read discrepancy, discrepancies, soft locked, and hard locked as query, queries, frozen, and locked respectively in the analyses.

OHSCDA includes the following analyses:

To locate a report, you need to select a dashboard and access a page that contains the report.

# Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)

Displays the number of follow up items by study-site, stacked by type. This report indicates which types of issues are occurring at a study-site most frequently.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • CRA dashboard, Monitoring Metrics page

  • Region Manager dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-1 describes the columns in the # Follow Up Items by Type (multiple Study-Sites) report.

Table A-1 # Follow Up Items by Type (multiple Study-Sites) (Report CDA-CO-810)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

# Follow Up Items by Type for Study-Site (Report CDA-CO-801)

Displays the number of follow up items identified for a study-site, by type. This report indicates which types of issues are occurring at a study-site most frequently.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-2 describes the columns in the # Follow Up Items by Type for Study-Site report.

Table A-2 # Follow Up Items by Type for Study-Site (Report CDA-CO-801)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

Approval & Verification Rates - Worst Performers (Report CDA-DM-350)

Identifies the top combined approval and verification rates for EDC studies. This report can be used to compare across sites to see quickly identify which sites and CRAs are taking the longest to approve and verify pages. This indicates the resource shortfalls, process inefficiencies, and potential training needs.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Home page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-3 describes the columns in the Approval and Verification Rates - Worst Performers report.

Table A-3 Approval and Verification Rates - Worst Performers (Report CDA-DM-350)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Approved

Received CRFs.% eCRFs Approved / Entry Complete

NA

Verified

Received CRFs.% eCRFs Verified / Entry Complete

Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

Lists all monitoring reports that have been approved, where the number of days from Visit Report Completed to Visit Report Approved exceeds the overall target.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-4 describes the columns in the Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved analysis.

Table A-4 Approved Reports that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-825)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

"- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]"

Average Days from Complete to Initially Approved (Report CDA-DM-325)

Identifies the average number of days for eCRFs to be approved following entry completion. This report indicates the lag between when an eCRF was entered to when it was initially approved. This measure can be used to compare site performance, and to highlight poor performing sites. When compared across studies, it can be an indicator of study site team inefficiencies.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Graph, table (optional)

Location

  • CRA dashboard, Performance page

  • Data Manager - EDC dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-5 describes the columns in the Average Days from Complete to Initially Approved - Top 25 report.

Table A-5 Average Days from Complete to Initially Approved - Top N (Report CDA-DM-325)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Avg # Days from eCRF Entry Complete to Initially Approved

Received CRFs.Avg # Days from eCRF Entry Complete to Initially Approved

Average Days from Complete to Initially Verified (Report CDA-DM-330)

Identifies the average number of days for eCRFs to be verified following entry completion. This report indicates the lag between when an eCRF was entered to when it was initially verified. This measure can be used to compare site performance, and can be used to infer the performance of the sites' CRA. When compared across studies, it can be an indicator of study team inefficiencies.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Graph, table (optional)

Location

  • CRA dashboard, Performance page

  • Data Manager - EDC dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-6 describes the columns in the Average Days from Complete to Initially Verified - Top 25 report.

Table A-6 Average Days from Complete to Initially Verified - Top (Report CDA-DM-330)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Avg # Days from eCRF Complete to Initially Verified

Received CRFs.Avg # Days from eCRF Complete to Initially Verified

Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

Identifies the average number of days discrepancies (queries) are within a grouping of review status. This report indicates which functional teams (or categories) are taking the longest to resolve or progress a discrepancy (query). This information can be used to identify process and resource inefficiencies.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Table Pivot table: rows=Study; columns=Categorized Review Status; cells=Average duration in Review Status, in days

Location

  • CRA dashboard, Performance page

  • Data Manager - EDC dashboard, Performance page

  • Data Manager - Paper dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-7 describes the columns in the Average Duration in Categorized Discrepancy (Query) Review Status report.

Table A-7 Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

Discrepancies (Queries)

State

Discrepancies.Discrepancy State

Discrepancies (Queries)

Categorized Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

Average duration in Review Status

Discrepancy Review Statuses.Avg # Days Discrepancy Ever in Review Status

Discrepancies (Queries)

# Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Average Days Discrepancy (Query) Open (Report CDA-DM-205)

Identifies distribution of open discrepancies (queries), by the number of days they have been open. This report indicates which sites have the oldest currently open discrepancies (queries).

Audience

  • Data Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Home page

  • Data Manager - EDC dashboard, Study Discrepancies (Queries) page

  • Data Manager - Paper dashboard, Home page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-8 describes the columns in the Average Days Discrepancy (Query) Open report.

Table A-8 Average Days Discrepancy (Query) Open (Report CDA-DM-205)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Site Name

Study Site.Site Name

NA

Avg Duration of Currently Open Discrepancies (Queries)

Study-site Metrics.Avg Duration of Currently Open Discrepancies

Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

Identifies the average number of days discrepancies (queries) are open within a review status. This report indicates the average length of time that discrepancies (queries) are remaining at a specific review state. This information can be used to identify process and resource inefficiencies.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Table Pivot table: rows=Study; columns=Review Status; cells=Average duration in Review Status Graph

Location

  • Data Manager - EDC dashboard, Performance page

  • Data Manager - Paper dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

  • Discrepancies.Discrepancy State

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-9 describes the columns in the Average Duration of Open Discrepancies (Queries) in Review Statuses report.

Table A-9 Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study Name

Study-Site.Study Name

NA

Review Status

Discrepancy Review Statuses.Discrepancy Review Status

NA

Average duration in Review Status, in Days

Discrepancy Review Statuses.Avg # Days Open Discrepancy Ever in Review Status

Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

Lists all monitoring reports that have been completed, where the number of days from Site Visit Completed to Visit Report Completed exceeds the overall target.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-10 describes the columns in the Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed analysis.

Table A-10 Completed Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-823)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

"- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed"

Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

Identifies the top CRFs which are producing the most discrepancies (queries). A CRF which is associated with a high number of discrepancies (queries) is often an indication that the validation procedure or the CRF have been poorly designed. Alternatively, it can indicate a misunderstanding on the completion guidelines for the CRF, and can therefore imply a training need for the study site. Early identification of such issues, at an early stage in the study, can dramatically reduce the number of discrepancies (queries) created.

Audience

  • Data Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Home page

  • Data Manager - EDC dashboard, Study Discrepancies (Queries) page

  • Data Manager - Paper dashboard, Home page

Dimensions

  • CRF

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-11 describes the columns in the Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank report.

Table A-11 Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

CRF Name

CRF.Name

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

NA

Type

Discrepancies.Type

Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

Identifies how many discrepancies (queries) are open, by review status. This report indicates the number of open discrepancies (queries), within a number of categorized review groups. This information can be used to identify which functional team or area has the most outstanding discrepancies (queries), which could indicate a resource shortage.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Table Pivot table: rows=Study; columns=Categorized Review Status; cells=#Open Discrepancies (Queries) Graph attached to the Pivot table

Location

  • Data Manager - EDC dashboard, Discrepancy (Query) Workload page

  • Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

Table A-12 describes the columns in the Counts of Categorized Open Discrepancies (Queries), by Review Status report.

Table A-12 Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

Discrepancies (Queries)

Categorized Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

# Open Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

Identifies the number of open and closed discrepancies (queries), by review status. This report indicates which review states are creating the largest volumes of discrepancies (queries). This information can be used to identify high discrepancy (query) volumes with a review state which may indicate lack of resource or process inefficiency.

Audience

  • Data Manager

  • Project Manager

Report Type

  • Table Pivot table: rows=Study; columns=Review Status; cells=#Discrepancies (Queries)

Location

  • Data Manager - EDC dashboard, Discrepancy (Query) Workload page

  • Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-13 describes the columns in the Counts of Discrepancies (Queries), by State and Review Status report.

Table A-13 Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study Name

Discrepancies (Queries)

Review Status

Discrepancy Review Statuses.Discrepancy Review Status

Discrepancies (Queries)

State

Discrepancies.Discrepancy State

Discrepancies (Queries)

# Discrepancies (Queries)

Discrepancies.# Total Discrepancies

Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

Identifies the distribution of discrepancies (queries), by validation procedure. This report indicates which validation procedures are creating the most discrepancies (queries). A procedure which is associated with a high number of discrepancies (queries) is often an indication that the validation procedure has been poorly designed, or that the related actual data exceeds any expected parameters.

Alternatively, it may indicate a misunderstanding on the completion guidelines for the CRF, and may therefore imply a training need for the study site. Early identification of such issues, at an early stage in the study, can dramatically reduce the number of discrepancies (queries) created.

Audience

  • Data Manager

Report Type

  • Graph, Table (optional)

Location

  • Data Manager - EDC dashboard, Home page

  • Data Manager - EDC dashboard, Study Discrepancies (Queries) page

  • Data Manager - Paper dashboard, Home page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-14 describes the columns in the Counts of Open Multivariate Discrepancies (Queries), by Procedure report.

Table A-14 Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Discrepancies (Queries)

Validation Procedure Name

Discrepancies.Validation Procedure Name

Discrepancies (Queries)

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Displays planned number of subjects for the study-site compared to enrolled and early terminated. This report indicates how well the study-site is progressing toward retention goals.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Study-Site Overview, Retention Overview page

Dimensions

  • All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-15 describes the columns in the Cumulative Enrollment and Early Term (Study-Site) report.

Table A-15 Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Subjects Planned for Study-Site

MAX(- Study-site Metrics.# Subjects Planned for Study-Site)

NA

# Enrolled

RSUM(- Study-site Metrics.# Subjects Enrolled)

NA

# Early Terminations

Study-site Metrics.# Early Terminations

Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

Displays planned number of subjects for the study-site compared to actual screened and enrolled. This report indicates how well the study-site is progressing toward recruitment goals.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Study-Site Overview page

  • Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

  • All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-16 describes the columns in the Cumulative Screening and Enrollment Bar (Study-Site) report.

Table A-16 Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Subjects Planned for Study-Site

MAX(- Study-site Metrics.# Subjects Planned for Study-Site)

NA

# Screened

RSUM(- Study-site Metrics.# Screened)

NA

# Enrolled

RSUM(- Study-site Metrics.# Subjects Enrolled)

Data Quality Study Risk Gauges (Report CDA-DM-500)

Displays gauges for data quality risk indicators at the study level.

Audience

  • Study Manager

  • Region Manager

  • Data Manager

  • CRA

Report Type

  • Gauge

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Data Quality Study-Site Risk Gauges (Report CDA-DM-505)

Displays gauges for data quality risk indicators at the study-site level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Detail Study-Site Map (Report CDA-CO-1201)

Displays study-sites geographically by # Enrolled, # Days Since Last Enrollment for Study-Site, # Subjects Enrolled Since Latest Site Visit and # Days Since Latest Site Visit.

Audience

  • CRA

Report Type

  • Map

Location

  • CRA dashboard, Study-Site Map page

Dimensions

None

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-17 describes the columns in the Detail Study-Site Map analysis.

Table A-17 Detail Study-Site Map (Report CDA-CO-1201)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

NA

Study-Site

Street Address

NA

Study-Site

City

NA

Study-Site

Country

NA

Study-Site

Latitude

NA

Study-Site

Longitude

NA

Study-Site Metrics

# Enrolled

NA

Study-Site Metrics

# Days Since Last Enrollment for Study-Site

NA

Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

NA

Study-Site Metrics

# Days Since Latest Site Visit

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Detailed Study Milestones Report (Report CDA-CO-102)

Lists (for a study) key milestone dates and enrollment, enrollment progress, and study-health indicator. This report indicates whether a study requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Study Manager Overview page

  • Executive Overview dashboard, Study List

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-18 describes the columns in the Detailed Study Milestones Report.

Table A-18 Detailed Study Milestones Report (Report CDA-CO-102)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Program

Study.Program

NA

Product

Study.Product

NA

Study

Study.Study

NA

Short Title

Study.Study Short Title

NA

Status

Study.Study Status

NA

Study Manager

Study.Study Manager

NA

Navigate to detail

NA

- Study Original Planned Dates

Planned 1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Original Planned Dates

Planned 1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Metrics

1st Site Initiated Date

CONCAT(CONCAT('Planned: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS char)),CONCAT(CONCAT(' LE: ',CAST("- Study Original Planned Dates"."Planned 1st Site Initiated Date" AS CHAR)),CONCAT(' Actual: ',CAST("- Study Metrics"."1st Site Initiated Date" AS CHAR))))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]"as char(40)))

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:' , cast(MAX("- Study Metrics"."% Planned Subjects Enrolled (Study)") as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:' , cast(MAX("- Study Metrics"."% Planned Subjects Randomized (Study)") as char(40)))

- Study Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Subjects Early Terminated for Study" as char(40)))

- Study Metrics

% Subjects Early Terminated for Study

CONCAT('Expected:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Subjects Early Terminated for Study" as char(40)))

- Study Metrics

% of Planned Sites Initiated

"- Study Metrics"."% of Planned Sites Initiated"

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('ActualL(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies")

- Discrepancies (Queries)

# Total Discrepancies (Queries)

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies")

- Received CRFs

# eCRFs To Be Approved

CONCAT('Actual:',cast("- Received CRFs"."# eCRFs To Be Approved" as char(40)))

- Received CRFs

# eCRFs To be Verified

CONCAT('Actual:',cast("- Received CRFs"."# eCRFs To be Verified" as char(40)))

- Received CRFs

# CRFs Soft- Locked (Frozen)

CONCAT('Actual:',cast("- Received CRFs"."# CRFs Soft- Locked" as char(40)))

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

CONCAT('Actual:',cast(("- Received CRFs"."% CRFs Soft Locked / Entry Complete") as char(40)))

- Received CRFs

# CRFs Hard-Locked (Locked)

CONCAT('Actual:',cast("- Received CRFs"."# CRFs Hard-Locked" as char(40)))

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

CONCAT('Actual:',cast(("- Received CRFs"."% CRFs Hard Locked / Entry Complete") as char(40)))

- Study Metrics

KPI Flag

"- Study Metrics"."KPI Flag"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Sites Recruiting 0 Subjects" as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."% Sites Recruiting 0 Subjects" as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]",1)) as char(40)))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]",1)) as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]",1)) as char(40)))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]",1)) as char(40)))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]",1) as char(40)))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]",1) as char(40)))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)",1)) as char(40)))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)",1)) as char(40)))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)",2)) as char(40)))

- Study Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)",2)) as char(40)))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)",2)) as char(40)))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('[Overall Target]:',cast(MIN("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(MAX(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)",2)) as char(40)))

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Metrics

Retention Flag

"- Study Metrics"."Retention Flag"

- Study Metrics

Retention Detail Reason

"- Study Metrics"."Retention Detail Reason"

- Study Metrics

# Study-Sites Planned for Study

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Metrics

# Study-Sites Initiated

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."Database Lock Date" as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Key Dates"."[Clinical Study Report Date]" as char(40)))

- Study Key Dates

[Protocol Approved Date]

CONCAT('Actual:' , cast(MAX("- Study Key Dates"."[Protocol Approved Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Identifies the rate of discrepancies (queries) per pages entered. This report displays the top studies and associated sites which have the highest numbers of discrepancies (queries) per page. This information can be used to identify poor performance across studies and across sites.

Audience

  • Data Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Quality page

  • Data Manager - Paper dashboard, Quality page

Dimensions

  • Study-Site

Supplementary Prompts

  • Top N

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-19 describes the columns in the Discrepancies (Queries) per Pages Entered - Top N report.

Table A-19 Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study

Study-Site.Study Name

NA

Total Discrepancies (Queries) per CRF

Study-site Metrics.Total Discrepancies per CRF

Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

Identifies the rate of discrepancies (queries) per subjects enrolled. This report identifies the top studies and associated sites which have the highest numbers of discrepancies (queries) per enrolled subject. This information can be used to identify poor performance across studies and across sites.

Audience

  • Data Manager

Report Type

  • Graph, Table (optional)

Location

  • Data Manager - EDC dashboard, Quality page

  • Data Manager - Paper dashboard, Quality page

Dimensions

  • Study-Site

Supplementary Prompts

  • Top N

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-20 describes the columns in the Discrepancies (Queries) per Subjects Enrolled report.

Table A-20 Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study Name

Study-Site.Study Name

NA

Total Discrepancies (Queries) per Enrolled Subject

Study-Site Metrics.Total Discrepancies per Enrolled Subject

Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Identifies how many discrepancies (queries) are open and closed. In addition, the report also shows ratios of the number of discrepancies (queries) per CRF entered. If these ratios vary significantly by site they may indicate a poor performing site with a training need.

Also, comparing these measures across studies can highlight inefficiencies between study teams, although it is important to also note that study variances are often a factor of study complexity and therapeutic area.

Audience

  • Data Manager

  • CRA

Report Type

  • Table

Location

  • Data Manager - EDC dashboard, Discrepancy (Query) Workload page

  • Data Manager - Paper dashboard, Discrepancy (Query) Workload page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-21 describes the columns in the Discrepancy (Query) Overview with Ratios report.

Table A-21 Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# CRFs Present

Received CRFs.# CRFs Present

# Discrepancies (Queries)

Open

Discrepancies.# Open Discrepancies

# Discrepancies (Queries)

Closed

Discrepancies.# Closed Discrepancies

# Discrepancies (Queries)

Total

Discrepancies.# Total Discrepancies

Discrepancies (Queries) per Received CRF

Open

Study-site Metrics.Open Discrepancies per CRF

Discrepancies (Queries) per Received CRF

Total

Study-site Metrics.Total Discrepancies per CRF

Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

Displays (by document type) the median days a document has been outstanding. This report indicates how long have documents been outstanding. It also indicates the documents that lag the most.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Site Document Metrics page

  • Study-Site Overview dashboard, Site Document Metrics page

  • Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-22 describes the columns in the Document Collection Cycle Times - Days Outstanding by Type report.

Table A-22 Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Document Type

Document Metrics.Activity Type

NA

Median # Days Document Outstanding

Document Metrics.Avg # Days Document Outstanding MEDIAN(- Document Metrics.# Days Document Outstanding BY - Document Metrics.Activity Type)

Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Lists the cycle times for all documents collected for the study. This report indicates the number of days a document has been outstanding, or how long it took to receive from the site.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Site Document Metrics page

  • Study-Site Overview dashboard, Site Document Metrics page

  • Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-23 describes the columns in the Document Collection Cycle Times (Study-Site) report.

Table A-23 Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Study Region

Study-Site.Study Region

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Document Received Date

Document Metrics.Document Received Date

NA

# Days from Document Sent to Document Received

Document Metrics.# Days from Document Sent to Document Received

NA

# Days Document Outstanding

Document Metrics.# Days Document Outstanding

Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

Displays (by document type) the average turn around time from document sent to document received. This report indicates if essential documents are being gathered on time, and how long does it typically take to receive a document. It also indicates the documents that lag the most.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Site Document Metrics page

  • Study-Site Overview dashboard, Site Document Metrics page

  • Study-Region Overview dashboard, Study-Site Document Metrics page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-24 describes the columns in the Document Collection Cycle Times -Turn Around Time by Type report.

Table A-24 Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Document Type

Document Metrics.Activity Type

NA

Median # Days from Document Sent to Document Received

Document Metrics.Avg # Days from Document Sent to Document Received MEDIAN(- Document Metrics.# Days from Document Sent to Document Received BY - Document Metrics.Activity Type)

Documents List (Multiple Study-Sites) (Report CDA-CO-601)

Lists all site documents collected, including document status, sent date, received date, and comments. This report indicates which study-site-level documents have been collected or are missing.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Document List page

Dimensions

  • None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-25 describes the columns in the Documents List (Multiple Study-Sites) report.

Table A-25 Documents List (Multiple Study-Sites) (Report CDA-CO-601)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Indicator

TBD

NA

Document Comments

Document Metrics.Document Comments

Documents List (Study Region) (Report CDA-CO-610)

Lists all study-region documents collected, including document status, sent date, received date, and comments. This report indicates which study-level documents have been collected or are missing.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Study-Region Overview dashboard, Region Document List page

Dimensions

  • NA

Supplementary Prompts

  • Document Page Prompt Filter (existing Filter from the previous release

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-26 describes the columns in the Documents List (Study Region) analysis.

Table A-26 Documents List (Study Region) (Report CDA-CO-610)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Document Metrics

Activity Type

"- Document Metrics"."Activity Type"

- Document Metrics

Document Name

"- Document Metrics"."Document Name"

- Document Metrics

Document Sent Date

"- Document Metrics"."Document Sent Date"

- Document Metrics

Document Received Date

"- Document Metrics"."Document Received Date"

- Document Metrics

Document Expiration Date

"- Document Metrics"."Document Expiration Date"

- Document Metrics

Document Comments

"- Document Metrics"."Document Comments"

- Document Metrics

Document Expiration Date Indicator

CASE WHEN "- Document Metrics"."Document Expiration Date" < VALUEOF(CURRENT_DAY) THEN '1-Red' WHEN "- Document Metrics"."Document Expiration Date" > VALUEOF(CURRENT_DAY) AND "- Document Metrics"."Document Expiration Date" <= TIMESTAMPADD(SQL_TSI_DAY, 30,VALUEOF(CURRENT_DAY) ) THEN '2-Yellow' WHEN "- Document Metrics"."Document Expiration Date" > TIMESTAMPADD(SQL_TSI_DAY, 30,VALUEOF(CURRENT_DAY) ) THEN '3-Green' END

Documents List (Study-Site) (Report CDA-CO-603)

Lists all site documents collected, including document status, sent date, received date, and comments. This report indicates which study-site-level documents have been collected or are missing.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Document List page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-27 describes the columns in the Documents List (Study-Site) report.

Table A-27 Documents List (Study-Site) (Report CDA-CO-603)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Indicator

TBD

NA

Document Comments

Document Metrics.Document Comments

Enrollment Overview By Site (Report CDA-CO-426)

Lists (by program, study, and region) all sites and the number of planned and actual subjects enrolled. This report indicates how well are we progressing against planned enrollment. It also shows the progress of subject recruitment, and how many subjects have been screened, enrolled, and randomized. This report also indicates the progress of each region towards enrollment.

Audience

  • Study Manager

  • CRA

Report Type

  • Pivot Table

Location

  • Study Overview dashboard, Study Region Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-28 describes the columns in the Enrollment Overview By Site report.

Table A-28 Enrollment Overview By Site (Report CDA-CO-426)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

Study Region Status

Region.Region Status

NA

Study-Site ID#

Study-Site.Study-Site ID#

NA

Site Name

Study-Site.Site Name

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study-Site Status

Study-Site.Study-Site Status

NA

CRA

Study-Site.CRA

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Study Overview, Recruitment Overview page

Dimensions

  • Study-Site

  • All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-29 describes the columns in the Enrollment Progress Over Time (Study Level) report.

Table A-29 Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

- All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Enrolled (Cumulative)

RSUM(- Study-site Metrics.# Subjects Enrolled)

Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

  • Region Manager, Study Manager, Executive Manager, Program Manager

Report Type

  • View Selector (Chart, Table)

Location

  • Study-Region Overview dashboard, Recruitment Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-30 describes the columns in the Enrollment Progress Over Time (Study-Region Level) analysis.

Table A-30 Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

Study-Region

Study

"Study-Region"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

- Study-Site Metrics

# Enrolled

IFNULL(RSUM("- Study-Site Metrics"."# Enrolled"), 0) + @{pv_subj_enrolled_stdy_reg}

Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

Shows cumulative actual enrollment over time, compared to static plan (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject recruitment. It also indicates how well we are progressing against planned enrollment.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

  • Study-Site All-Purpose Date

Supplementary Prompts

  • Page Specific Year and Month Between prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-31 describes the columns in the Enrollment Progress Over Time (Study-Site Level) report.

Table A-31 Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

# Subjects Enrolled (Cumulative)

RSUM(- Study-site Metrics.# Subjects Enrolled)

NA

Year and Month

All Purpose Date.Year and Month

Essential Documents Study Risk Gauges (Report CDA-CO-620)

Displays gauges for essential document risk indicators at the study level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)

Displays gauges for essential document risk indicators at the study-site level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Executive Study-Site Map (Report CDA-CO-1203)

Displays the following metrics by country: # Sites Recruiting 0 Subjects, # Sites Recruiting 1 or More Subjects, # Sites Recruiting at Least 90% of Planned Subjects, Median Initial IRB/EC Approval to Site Initiated (# Days), Median Site Initiated to 1st Subject Enrolled (# Days) and # Study-Sites Initiated.

Audience

  • Executive

Report Type

  • Map

Location

  • Executive dashboard, Map of Study-Sites, Region manager dashboard, Study-Region Overview dashboard, Overview page

Dimensions

None

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-32 describes the columns in the Executive Study-Site Map analysis.

Table A-32 Executive Study-Site Map (Report CDA-CO-1203)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Country

NA

Study-Region Metrics

# Sites Recruiting 0 Subjects

NA

Study-Region Metrics

# Sites Recruiting 1 or More Subjects

NA

Study-Region Metrics

# Sites Recruiting at Least 90% of Planned Subjects

NA

Study-Region Metrics

Median Initial IRB/EC Approval to Site Initiated (# Days)

NA

Study-Region Metrics

Median Site Initiated to 1st Subject Enrolled (# Days)

NA

Study-Region Metrics

# Study-Sites Initiated

NA

High Level Study-Site Map (Report CDA-CO-1202)

Displays study-sites geographically by # Enrolled, # Days Since Last Enrollment for Study-Site, # Subjects Enrolled Since Latest Site Visit and # Days Since Latest Site Visit. Also displays the following metrics by country: # Enrolled, # Current Active Subjects and # Early Terminations.

Audience

  • Region Manager, Study Manager, CRA, Executive

Report Type

  • Map

Location

  • Executive dashboard, Study-Site Map, Region manager dashboard, Map of Study-Sites Study Overview dashboard, Map of Study-Sites Study Manager dashboard, Map of Study-Sites page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-33 describes the columns in the High Level Study-Site Map analysis.

Table A-33 High Level Study-Site Map (Report CDA-CO-1202)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

NA

Study-Site

Street Address

NA

Study-Site

City

NA

Study-Site

Country

NA

Study-Site Metrics

# Enrolled

NA

Study-Site Metrics

# Current Active Subjects

NA

Study-Site Metrics

# Early Terminations

NA

Study-Site Metrics

# Days Since Last Enrollment for Study-Site

NA

Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

NA

Study-Site Metrics

# Days Since Latest Site Visit

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Lists initiated study-sites and their progress toward recruitment goals, as well as details including days since initiation and days since latest enrollment.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Initiating and Recruiting Study-Sites page

  • Study-Region Overview dashboard, Recruitment Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-34 describes the columns in the Initiated Study-Sites with Recruitment Counts report.

Table A-34 Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

% to Plan

Enrollment

Study-site Metrics.% Enrolled to Total Planned at Study-Site

% to Plan

Randomization

Study-site Metrics.% Randomized vs. Planned - Study-Site

# Subjects

Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

# Subjects

# Screened

Study-site Metrics.# Screened

# Subjects

# Screen Failure

Study-site Metrics.# Screen Failure

# Subjects

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# Subjects

# Randomized

Study-site Metrics.# Randomized

Site Initiation

Site Initiated Date

Study-Site.Site Initiated Date

Site Initiation

# Days Since Initiation

Study-site Metrics.# Days Since Initiation

Latest Subject Enrolled

Date

Study-site Metrics.Latest Subject Enrolled Date

Latest Subject Enrolled

# Days Since

Study-site Metrics.# Days Since Last Enrollment for Study-site

NA

Navigate to detail

NA

Investigator Contact and Studies List (Report CDA-CO-202)

Lists contact information for an investigator, as well as a list of the studies they have participated in. This report provides contact information on principal investigators.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

None

Dimensions

  • Study-Site

  • Principal Investigator

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

Table A-35 describes the columns in the Investigator Contact and Studies List report.

Table A-35 Investigator Contact and Studies List (Report CDA-CO-202)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Investigator Email Address

Investigator.Investigator Email Address

NA

Investigator Fax/Phone #

Investigator.Investigator Fax/Phone #

NA

Investigator Street Address

Investigator.Investigator Street Address

NA

Investigator Street Address 2

Investigator.Investigator Street Address 2

NA

Investigator Street Address 3

Investigator.Investigator Street Address 3

NA

Investigator City

Investigator.Investigator City

NA

Investigator State

Investigator.Investigator State

NA

Investigator Postal Code

Investigator.Investigator Postal Code

NA

Investigator Country

Investigator.Investigator Country

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

Issue Management Study Risk Gauges (Report CDA-CO-840)

Displays gauges for issue management risk indicators at the study level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Issue Management Study-Site Risk Gauges (Report CDA-CO-845)

Displays gauges for issue management risk indicators at the study-site level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Key Cycle Times for Paper Studies (Report CDA-DM-400)

Identifies key cycle times for paper studies, and can be used to compare studies against each other. This report indicates key lags in process steps and potential inefficiencies.

Audience

  • Data Manager

  • Project Manager

Report Type

  • Table

Location

  • Data Manager - Paper dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-36 describes the columns in the Key Cycle Times for Paper Studies report.

Table A-36 Key Cycle Times for Paper Studies (Report CDA-DM-400)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# pCRFs

Present

Received CRFs.# pCRFs Present

# pCRFs

Entry Complete

Received CRFs.# pCRFs Entry Complete

Average Days

Visit to First Entry

Received CRFs.Avg # Days from pCRF Visit to First Entry

Average Days

First Entry to Second Entry Complete

Received CRFs.Avg # Days from pCRF First Entry to Second Entry Complete

Average Days

Visit to Entry Complete

Received CRFs.Avg # Days from pCRF Visit to Entry Complete

Average Days

Entry Complete to Soft Locked (Frozen)

Received CRFs.Avg # Days from pCRF Entry Complete to Soft Locked

Key EDC Cycle Times (Report CDA-DM-300)

Identifies the key cycle times for EDC studies, and can be used to compare sites within study, and to compare studies against each other. This report indicates key lags in process steps, and potential inefficiencies.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Table

Location

  • CRA dashboard, Performance page

  • Data Manager - EDC dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-37 describes the columns in the Key EDC Cycle Times report.

Table A-37 Key EDC Cycle Times (Report CDA-DM-300)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

Study-Site

Study Name

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Entry Complete

Received CRFs.# eCRFs Entry Complete

Average Days From Visit To

Entry Complete

Received CRFs.Avg # Days from eCRF Visit to eCRF Complete

Average Days From Entry Completion To

Initially Approved

Received CRFs.Avg # Days from eCRF Entry Complete to Initially Approved

Average Days From Entry Completion To

Initially Verified

Received CRFs.Avg # Days from eCRF Complete to Initially Verified

Average Days From Entry Completion To

Soft Locked (Frozen)

Received CRFs.Avg # Days from eCRF Complete to Soft Locked

Key EDC Processing Volumes (Report CDA-DM-305)

Identifies the key processing volumes for EDC studies. This report displays page processing volumes for EDC studies. It also displays eCRFs processed and to be processed.

Ratios of approved and verified data can also be used to show progress through the study. This report can be used to understand resource requirements based on work volumes.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Table

Location

  • CRA dashboard, eCRF Workload page

  • Data Manager - EDC dashboard, eCRF Workload page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-38 describes the columns in the Key EDC Processing Volumes report.

Table A-38 Key EDC Processing Volumes (Report CDA-DM-305)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Name

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies

# eCRFs

Entry Complete

Received CRFs.# eCRFs Entry Complete

# eCRFs

Not Verified

Received CRFs.# eCRFs Not Verified

# eCRFs

Verified

Received CRFs.# eCRFs Verified

# eCRFs

Not Approved

Received CRFs.# eCRFs To Be Approved

# eCRFs

Approved

Received CRFs.# eCRFs Approved

# eCRFs

Soft Locked (Frozen)

Received CRFs.# eCRFs Soft Locked

# eCRFs

Hard Locked (Locked)

Received CRFs.# eCRFs Hard Locked

% of Entry-Complete eCRFs

Approved

Received CRFs.% eCRFs Approved / Entry Complete

% of Entry-Complete eCRFs

Verified Foot 1  Conditional Formatting Threshold: Yellow - between 30 and 50 Conditional Formatting Threshold: Red - less than or equal to 30

Received CRFs.% eCRFs Verified / Entry Complete

% of Entry-Complete eCRFs

Soft Locked (Frozen)

Received CRFs.% eCRFs Soft Locked / Entry Complete

% of Entry-Complete eCRFs

Hard Locked (Locked)

Received CRFs.% eCRFs Hard Locked / Entry Complete

NA

Navigate to Detail

NA

Key Paper Processing Volumes (Report CDA-DM-405)

Identifies key page processing volumes for paper studies. This report displays pages processed and to be processed. This information can be used to understand resource requirements based on work volumes.

Audience

  • Data Manager

  • Project Manager

Report Type

  • Table

Location

  • Data Manager - Paper dashboard, Page Workload page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-39 describes the columns in the Key Paper Processing Volumes report.

Table A-39 Key Paper Processing Volumes (Report CDA-DM-405)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study Name

NA

#Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Open Discrepancies (Queries)

Discrepancies.# Open Discrepancies Note: This is all discrepancies, not just those arising from CRFs.

# CRFs

Present

Received CRFs.# pCRFs Present

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

# CRFs

Entry Complete

Received CRFs.# pCRFs Entry Complete

# CRFs

Blank

Received CRFs.# pCRFs Blank

# CRFs

Soft Locked (Frozen)

Received CRFs.# pCRFs Soft Locked

# CRFs

Hard Locked (Locked)

Received CRFs.# pCRFs Hard Locked

% of Entry-Complete eCRFs

Soft Locked (Frozen)

Received CRFs.% pCRFs Soft Locked / Entry Complete

% of Entry-Complete eCRFs

Hard Locked (Locked)

Received CRFs.% pCRFs Hard Locked / Entry Complete

NA

Navigate to Detail

NA

Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)

Line-bar graph that shows the region median for the following monitoring measures compared to the number of completed site visits, by month:

  • # Days from Site Visit Completed to Visit Report Completed

  • # Days from Monitoring Report Completed to Monitoring Report Approved

  • # Days from Follow Up Item Identified to Follow Up Item Resolved

Audience

  • Region Manager

Report Type

  • View Selector (Chart, Table)

Location

  • Region Manager dashboard, Monitoring Metrics page

Dimensions

  • Visit Report Completed Date

Supplementary Prompts

  • Site Visit Start Date page prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-40 describes the columns in the Key Performance Indicators Over Time: Monitoring (Region Manager) analysis.

Table A-40 Key Performance Indicators Over Time: Monitoring (Region Manager) (Report CDA-CO-1112)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Month

"- Visit Report Completed Date"."Year and Month"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

- Follow Up Item Metrics

# Days from Site Visit Completed to Follow Up Item Completed

MEDIAN("- Follow Up Item Metrics"."# Days from Site Visit Completed to Follow Up Item Completed")

Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

Line graph that shows the following measures by quarter at the overall level:

  • Median Critical Document Package Complete to Site Initiated

  • Median LSLV to DB Lock

  • Median Protocol Approved to 1st Site Initiated

  • Median Protocol Approved to 1st Subject Enrolled

  • Median Site Visit Completed to Visit Report Completed

  • Median Visit Report Completed to Visit Report Approved

This report shows the overall time trend for KPIs at the executive level.

Audience

  • Executive

Report Type

  • Line Graph (View selector)

Location

  • Executive dashboard, Overview page

Dimensions

  • All Purpose Date

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-41 describes the columns in the Key Performance Indicators Over Time (Executive View) analysis.

Table A-41 Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year

"- All Purpose Date"."Year"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

MEDIAN("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]")

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]")

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]")

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

Line and line-bar graphs that show the overall median compared to the overall target for Critical Document Package Complete to Site Initiated (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • All Purpose Date

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-42 describes the columns in the KPI Summary: CDP Complete to Site Initiated (Executive View) analysis.

Table A-42 KPI Summary: CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

- Study-Site Metrics

# Study-Sites

"- Study-Site Metrics"."# Study-Sites"

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

"Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

Line and line-bar graphs that show the region median compared to overall median and overall target for Critical Document Package Completed to Site Initiated (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

  • Region Manager Study Manager

Report Type

  • View Selector (Multiple Graphs)

Location

  • Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

  • Study-Site, All Purpose Date

Supplementary Prompts

  • Year and Month Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-43 describes the columns in the KPI Summary: CDP Completed to Site Initiated (Region Manager View) analysis.

Table A-43 KPI Summary: CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

"Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]"

- Study-Site Metrics

Critical Document Package Complete to Site Initiated (# Days)

MEDIAN("- Study-Site Metrics"."Critical Document Package Complete to Site Initiated (# Days)")

- Study-Site Metrics

# Study-Sites

"- Study-Site Metrics"."# Study-Sites"

- Overall Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

"- Overall Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]"

- All Purpose Date

Year

"- All Purpose Date"."Year"

KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)

Line and line-bar graphs that show the overall median compared to the overall target for Last Subject Last Visit to Database Lock (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • All Purpose Date, Overall Level Targets

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-44 describes the columns in the KPI Summary: LSLV to Database Lock (Executive View) analysis.

Table A-44 KPI Summary: LSLV to Database Lock (Executive View) (Report CDA-CO-906)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Quarter

"- All Purpose Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

"Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

MEDIAN("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]")

KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

Line and line-bar graphs that show the overall median compared to the overall target for Protocol Approved to 1st Site Initiated (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • 1st Site Initiated Date, Overall Level Targets

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-45 describes the columns in the KPI Summary: Protocol Approved to 1st Site Initiated (Executive View) analysis.

Table A-45 KPI Summary: Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- 1st Site Initiated Date

Year and Quarter

"- 1st Site Initiated Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]")

KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

Line and line-bar graphs that show the overall median compared to the overall target for Protocol Approved to 1st Subject Enrolled (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • 1st Subject Enrolled Date, Overall level Targets

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-46 describes the columns in the KPI Summary: Protocol Approved to 1st Subject Enrolled (Executive View) analysis.

Table A-46 KPI Summary: Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- 1st Subject Enrolled Date

Year and Quarter

"- 1st Subject Enrolled Date"."Year and Quarter"

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]")

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

MEDIAN("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]")

KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

Line and line-bar graphs that show the overall median compared to the overall target for Site Visit Completed to Visit Report Completed (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • Visit Report Completed Date, Overall Level Targets

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-47 describes the columns in the KPI Summary: Site Visit Completed to Visit Report Completed (Executive View) analysis.

Table A-47 KPI Summary: Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Quarter

"- Visit Report Completed Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

KPI Summary - Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

Line and line-bar graphs that show the region median compared to overall median and overall target for Site Visit Completed to Visit Report Completed (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

  • Region Manager

  • Study Manager

Report Type

  • View Selector (Multiple Graphs)

Location

  • Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

  • All Purpose Date

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-48 describes the columns in the KPI Summary: Site Visit Completed to Visit Report Completed (Region Manager View) analysis.

Table A-48 KPI Summary: Site Visit Completed to Visit Report Completed (Region Manager View) (Report CDA-CO-1104)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Visit Report Completed Date

Year and Quarter

"- Visit Report Completed Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Completed to Visit Report Completed

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

- Overall Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

"- Overall Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)"

- Visit Report Completed Date

Year

"- Visit Report Completed Date"."Year"

KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Line and line-bar graphs that show the region median compared to overall median and overall target for Visit Report Completed to Visit Report Approved (# Days), by quarter. Also includes a count of the number of studies that makes up the region median. This report compares region performance to overall performance and overall target for a given KPI.

Audience

  • Region Manager Study Manager

Report Type

  • View Selector (Multiple Graphs)

Location

  • Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

  • Visit Report Approved Date

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-49 describes the columns in the KPI Summary: Visit Report Completed to Approved (Region Manager View) analysis.

Table A-49 KPI Summary: Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Visit Report Approved Date

Year and Quarter

"- Visit Report Approved Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Site Visit Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Site Visit Completed to Visit Report Approved]")

- Overall Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

"- Overall Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)"

- Visit Report Approved Date

Year

"- Visit Report Approved Date"."Year"

KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

Line and line-bar graphs that show the overall median compared to the overall target for Visit Report Completed to Visit Report Approved (# Days), by quarter. Also includes a count of the number of studies that make up the overall median. This report compares overall performance to the overall target for a given KPI.

Audience

  • Executive

Report Type

  • Multiple Graphs (View selector)

Location

  • Executive dashboard, KPI Summary page

Dimensions

  • Visit Report Approved Date, Overall Level Targets

Supplementary Prompts

  • Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-50 describes the columns in the KPI Summary: Visit Report Completed to Visit Report Approved (Executive View) analysis.

Table A-50 KPI Summary: Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Visit Report Approved Date

Year and Quarter

"- Visit Report Approved Date"."Year and Quarter"

- Study-Site Metrics

# Site Visits

"- Study-Site Metrics"."# Site Visits"

Overall Level Targets

[Target Site Visit Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Approved (# Days)]"

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

MEDIAN("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]")

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

List Discrepancy (Query) Details (Report CDA-DM-245)

Lists open discrepancies (queries) and associated details, and is used as a detailed drill down report to list all discrepancies (queries) and associated details. This report can be used to explore the open discrepancies (queries), and identify any patterns or clusters through the use of sorting.

Audience

  • Data Manager

Report Type

  • Table

Location

None

Dimensions

  • CRF

  • Study-Site

  • Subject

Supplementary Prompts

  • Subject.Subject ID

  • Discrepancies.Visit Name

  • Discrepancies.CRF Name

  • Discrepancies.Validation Procedure Name

  • Discrepancies.Current Review Status

  • Discrepancies.Discrepancy State

Reports Referenced

None

Column Descriptions

Table A-51 describes the columns in the List Discrepancy (Query) Details report.

Table A-51 List Discrepancy (Query) Details (Report CDA-DM-245)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

Study-Site

Study

Study-Site.Study Name

NA

Site

Study-Site.Site Name

NA

Subject ID

Subject.Subject ID

Visit

Name

Discrepancies.Visit Name

Visit

Number

Discrepancies.Complete Visit Number

NA

Days Open

Discrepancies.# Days Discrepancy Open

CRF

Name

CRF.Name

CRF

Page Section

Discrepancies.CRF Page Section

CRF

Question Group

Discrepancies.CRF Question Group

CRF

Question Name

Discrepancies.CRF Question Name

CRF

Question Occurrence

Discrepancies.CRF Question Occurrence

Discrepancy (Query)

Discrepancy (Query) ID

Discrepancies.Discrepancy ID

Discrepancy (Query)

Procedure Name

Discrepancies.Validation Procedure Name

Discrepancy (Query)

Review Status

Discrepancies.Current Review Status

Discrepancy (Query)

Comment Text

Discrepancies.Comment Text

Discrepancy (Query)

Sent in DCF

Discrepancies.Sent in DCF

Discrepancy (Query)

State

Discrepancies.Discrepancy State

List of Follow Up Items (Report CDA-CO-803)

Lists follow up items, including type, comments, and key dates.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

None

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

Table A-52 describes the columns in the List of Follow Up Items report.

Table A-52 List of Follow Up Items (Report CDA-CO-803)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Follow Up Item

Type

Follow Up Item Metrics.Follow Up Item Type

Follow Up Item

Description

Follow Up Item Metrics.Follow Up Item Description

Follow Up Item

Comments

Follow Up Item Metrics.Follow Up Item Comments

Follow Up Item

Status

Follow Up Item Metrics.Follow Up Item Status

Follow Up Item

Created Date

Follow Up Item Metrics.Follow Up Item Created Date

Follow Up Item

Due Date

Follow Up Item Metrics.Follow Up Item Due Date

Follow Up Item

Completed Date

Follow Up Item Metrics.Follow Up Item Completed Date

Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Identifies specific eCRFs, and the process steps they are awaiting. This report lists, for a subject, the eCRFs which are awaiting processing. This information can be used to drive an activity.

Audience

  • Data Manager

Report Type

  • Table

Location

  • Data Manager - EDC dashboard, Study Processing Detail page

Dimensions

  • CRF

  • Study-Site

  • Subject

Supplementary Prompts

  • Study

  • Study-Site

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

Table A-53 describes the columns in the Key EDC processing volumes report.

Table A-53 Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Study-Site

Site

Study-Site.Site Name

Subject

Subject ID

Subject.Subject ID

Visit

Name

Received CRFs.Visit Name

Visit

Number

Received CRFs.Complete Visit Number

Visit

Date

Received CRFs.Visit Date

CRF

Name

CRF.Name

Processing Required

Not Verified

Received CRFs.Is not in Verified state

Processing Required

Awaiting Re-verification

Received CRFs.Is Awaiting Re-Verification

Processing Required

Not Approved

Received CRFs.Is not in Approved state

Processing Required

Requires Re-Approval

Received CRFs.s Awaiting Re-Approval

Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Identifies specific CRFs, and the process steps they are awaiting. This report lists, for a subject, the pages which are awaiting processing. This information can be used to drive activity.

Audience

  • Data Manager

Report Type

  • Table

Location

  • Data Manager - Paper dashboard, Study Processing Detail page

Dimensions

  • CRF

  • Subject

Supplementary Prompts

  • Study

  • Study-Site

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

Table A-54 describes the columns in the Listing of Subject-Pages, Awaiting Paper Processing report.

Table A-54 Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

Visit

Name

Received CRFs.Visit Name

Visit

Number

Received CRFs.Complete Visit Number

Visit

Date

Received CRFs.Visit Date

CRF

Name

CRF.Name

Processing Required

Awaiting First Entry

Received CRFs.Is Awaiting First Entry completion

Processing Required

Awaiting Second Entry

Received CRFs.Is Awaiting Second entry completion

Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

Identifies sites who are slow at approving eCRFs. This report indicates the top 25 sites whose approval rates are less than 80% of those eCRFs entered. This information can be identify poor performing sites. Note: The 80% rate is based on those studies where the sites are requested to approve eCRFs immediately after entry. For those studies where this process is not relevant, the 80% threshold can be reduced.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Key Rates page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-55 describes the columns in the Low Approved to Entered Rate - Worst Performers report.

Table A-55 Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

% eCRFs Approved / Entry Complete

Received CRFs.% eCRFs Approved / Entry Complete

Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

Identifies sites where verification has been slow. This report displays the top sites whose verification rates are less than 50% of those pages entered. This information can be used to identify CRA resource shortfalls.

Audience

  • Data Manager

  • CRA

  • Project Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - EDC dashboard, Key Rates page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-56 describes the columns in the Low Verified to Entered Rate - Worst Performers report.

Table A-56 Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

% eCRFs Verified / Entry Complete

Received CRFs.% eCRFs Verified / Entry Complete

Median # Follow Up Items per Site for Study (Report CDA-CO-802)

Displays the median number of follow up items identified across all study-sites for a study, by type. This report indicates which types of issues are occurring at in the study most frequently.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-57 describes the columns in the Median # Follow Up Items per Site for Study report.

Table A-57 Median # Follow Up Items per Site for Study (Report CDA-CO-802)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Count of Follow Up Items

COUNT(- Follow Up Item Metrics.Follow Up Item Created Date)

NA

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

NA

Study

Study-Site.Study

Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

Displays monitoring report approval cycle times in the form of a scatter plot, compared to a static goal, over time. This report indicates how many visit report approvals have fallen above or below a threshold over time.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Manager dashboard, Monitoring Metrics page

  • CRA dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-58 describes the columns in the Monitoring Report Approval - Turnaround Time vs. Goal report.

Table A-58 Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Site Visit Report Completed Date

Site Visit.Site Visit Report Completed Date

NA

# Days from Visit Report Completed to Visit Report Approved

- Site Visit Metrics.# Days from Visit Report Completed to Visit Report Approved

NA

Target

12

Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

Displays the number of visit report approvals within 10 days, between 10 and 20 days, and greater than 20 days. Displays the information over time. This report indicates how many visit report approvals fall within designated thresholds.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Manager dashboard, Monitoring Metrics page

  • Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

  • All Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-59 describes the columns in the Monitoring Report Approval Turnaround Times report.

Table A-59 Monitoring Report Approval Turnaround Times (Report CDA-CO-817)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Days from Visit Report Completed to Visit Report Approved

Site Visit Metrics.# Days from Visit Report Completed to Visit Report Approved

NA

Category

TBD

Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

Displays the number of visit reports completed within 10 days, between 10 and 20 days, and greater than 20 days. Displays the information over time. This report indicates how many visit report completions fall within designated thresholds.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Manager dashboard, Monitoring Metrics page

  • CRA dashboard, Monitoring Metrics page

  • Region Manager dashboard, Visit Reports & Follow Up Items page

  • Monitoring Metrics page

Dimensions

  • All Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-60 describes the columns in the Monitoring Report Completion Turnaround Times report.

Table A-60 Monitoring Report Completion Turnaround Times (Report CDA-CO-820)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Days from Site Visit Completed to Visit Report Completed

Site Visit Metrics.# Days from Site Visit Completed to Visit Report Completed

NA

Indicator

TBD

Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

Shows count of outstanding visit reports, visit report approvals and follow up items

Audience

  • Region Manager

Report Type

  • Narrative

Location

  • Region Manager dashboard, Overview page

Dimensions

  • Study-Site

Supplementary Prompts

  • NA

Column Descriptions

Table A-61 describes the columns in the Monitoring Status Overview (Region Manager View) analysis

Table A-61 Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Visit Reports Awaiting Completion

sum("- Study-Site Metrics"."# Visit Reports Awaiting Completion")

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

sum("- Study-Site Metrics"."[# Visit Reports Awaiting Approval]")

- Site Visit Metrics

# Outstanding Follow Up Items

sum ("- Site Visit Metrics"."# Outstanding Follow Up Items")

Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

Shows count of outstanding visit reports, visit report approvals and follow up items

Audience

  • Study Manager

Report Type

  • Narrative

Location

  • Study Manager dashboard, Overview page

Dimensions

  • Study

Supplementary Prompts

  • NA

Reports Referencing This Report

None

Column Descriptions

Table A-62 describes the columns in the Monitoring Status Overview (Study Manager View) analysis.

Table A-62 Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Visit Reports Awaiting Completion

sum("- Study-Site Metrics"."# Visit Reports Awaiting Completion")

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

sum("- Study-Site Metrics"."[# Visit Reports Awaiting Approval]")

- Site Visit Metrics

# Outstanding Follow Up Items

sum ("- Site Visit Metrics"."# Outstanding Follow Up Items")

Number of Studies (Report CDA-CO-1001)

Pie chart that shows count of studies. Column selector allows user to view by Therapeutic Area, Program, or Phase.

Audience

  • Executive

Report Type

  • Pie Chart (View Selector)

Location

  • Executive dashboard, Overview page

Dimensions

  • Study

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-63 describes the columns in the Number of Studies analysis

Table A-63 Number of Studies (Report CDA-CO-1001)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Study Metrics

# Studies

"- Study Metrics"."# Studies"

Study

Study Phase

"Study"."Study Phase"

Study

Program

"Study"."Program"

Study

Therapeutic Area

"Study"."Therapeutic Area"

Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

Lists all completed monitoring reports that have not yet been approved, where the number of days since Monitoring Report Completed is within 5 days of meeting overall target. This report indicates which outstanding approvals are at risk of missing the overall target

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-64 describes the columns in the Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved analysis

Table A-64 Outstanding Approvals at Risk of Missing Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-826)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Site Visit Report Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

[Site Visit Report Approved Date]

"Site Visit"."[Site Visit Report Approved Date]"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" - 5) THEN 1 ELSE 0 END

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" - 5) THEN 1 ELSE 0 END

Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

Lists all completed monitoring reports that have not yet been approved, where the number of days since Monitoring Report Completed is greater than the overall target. This report indicates which outstanding approvals have already missed the overall target.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-65 describes the columns in the Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved analysis

Table A-65 Outstanding Approvals that Missed Target: Visit Report Completed to Visit Report Approved (Report CDA-CO-828)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Days Since Completed

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF(CURRENT_DAY))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

"Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"

Outstanding Documents List (Report CDA-CO-602)

Lists all site documents that have been sent but not received from the study-site. This report indicates which study-site-level documents need to be collected.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

None

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

Column Descriptions

The table describes the columns in the Outstanding Documents List report.

Table A-66 Outstanding Documents List (Report CDA-CO-602)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Days Since Doc Sent

TIMESTAMPDIFF(SQL_TSI_DAY, - Document Metrics.Document Sent Date,NOW())

NA

Document Comments

Document Metrics.Document Comments

Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

Lists the outstanding follow up items for the study. This report indicates which active issues the study is encountering during monitoring visits, and how long they've been open.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items - Study Overview report.

Table A-67 Outstanding Follow up Items - Study Overview (Report CDA-CO-805)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

CRA

Study-Site.CRA

Site Visit Follow Up Item Metrics

Follow Up Item Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Follow Up Item Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Follow Up Item Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Follow Up Item Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Follow Up Item Open

Follow Up Item Metrics.# Days Follow Up Item Open

Indicator

Indicator

TBD

Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

Lists the outstanding follow up items. This report indicates which active issues are occurring during monitoring visits, and how long they've been open.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, CRA Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (CRA View) report.

Table A-68 Outstanding Follow up Items (CRA View) (Report CDA-CO-806)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Site Visit Metrics

Type

Site Visit.Site Visit Type

Site Visit Metrics

Start Date

Site Visit.Site Visit Start Date

Site Visit Metrics

Completed Date

Site Visit.Site Visit Completed Date

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Outstanding

Follow Up Item Metrics.# Days Follow Up Item Outstanding

NA

Indicator

TBD

Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Lists the outstanding follow up items for the study. This report indicates which active issues the study is encountering during monitoring visits, and how long they've been open.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Monitoring Metrics page

  • Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (Study Manager View) report.

Table A-69 Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

CRA

Study-Site.CRA

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Open

Follow Up Item Metrics.# Days Follow Up Item Open

NA

Indicator

TBD

Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

Lists all follow up items that have not been completed in the study-region. This report indicates which follow up items need to be resolved.

Audience

  • Study Manager CRA

Report Type

  • Table

Location

  • Study-Region Overview dashboard, Visit Reports and Follow Up Items page

Dimensions

  • Study-Site

Supplementary Prompts

  • Visit Reports and Follow Up Items page prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-70 describes the columns in the Outstanding Follow up Items (Study-Region Overview) analysis

Table A-70 Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

- Follow Up Item Metrics

Follow Up Item Type

"- Follow Up Item Metrics"."Follow Up Item Type"

- Follow Up Item Metrics

Follow Up Item Status

"- Follow Up Item Metrics"."Follow Up Item Status"

- Follow Up Item Metrics

Follow Up Item Description

"- Follow Up Item Metrics"."Follow Up Item Description"

- Follow Up Item Metrics

Follow Up Item Comments

"- Follow Up Item Metrics"."Follow Up Item Comments"

- Follow Up Item Metrics

# Days Follow Up Item Open

"- Follow Up Item Metrics"."# Days Follow Up Item Open"

- Follow Up Item Metrics

# Days Follow Up Item Outstanding

"- Follow Up Item Metrics"."# Days Follow Up Item Outstanding"

- Follow Up Item Metrics

Indicator

CASE WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding" , 1)>60 THEN '1-Red' WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding", 1) BETWEEN 30 AND 60 THEN '2-Yellow' WHEN ROUND("- Follow Up Item Metrics"."# Days Follow Up Item Outstanding", 1)<30 THEN '3-Green' ELSE '' END

Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

Lists all follow up items that have not been completed. This report indicates which follow up items need to be resolved.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Follow up Items (Study-Site Overview) report.

Table A-71 Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Site Visit Metrics

Type

Site Visit.Site Visit Type

Site Visit Metrics

Start Date

Site Visit.Site Visit Start Date

Site Visit Metrics

Completed Date

Site Visit.Site Visit Completed Date

Site Visit Follow Up Item Metrics

Type

Follow Up Item Metrics.Follow Up Item Type

Site Visit Follow Up Item Metrics

Status

Follow Up Item Metrics.Follow Up Item Status

Site Visit Follow Up Item Metrics

Description

Follow Up Item Metrics.Follow Up Item Description

Site Visit Follow Up Item Metrics

Comments

Follow Up Item Metrics.Follow Up Item Comments

Site Visit Follow Up Item Metrics

# Days Open

Follow Up Item Metrics.# Days Follow Up Item Open

Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

Lists all monitoring reports awaiting approval. This report indicates which monitoring reports require an action: review and approval.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, CRA Overview page

Dimensions

  • Study-Site

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (CRA View) report.

Table A-72 Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

TBD

Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Lists the monitoring reports that have been completed but not yet approved. This report indicates which monitoring reports require approval.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Monitoring Metrics page

  • Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (Study Manager View) report.

Table A-73 Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

CRA

Study-Site.CRA

NA

Study-Site Status

Study-Site.Study-Site Status

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

Site Visit Type

Site Visit.Site Visit Type

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

TBD

Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)

Lists all monitoring reports awaiting approval in the study region. This report indicates which monitoring reports require an action: review and approval.

Audience

  • Study Manager CRA

Report Type

  • Table

Location

  • Study-Region Overview dashboard, Monitoring Reports and Follow Up Items page

Dimensions

  • Study-Site

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-74 describes the columns in the Outstanding Visit Report Approvals (Study-Region) analysis

Table A-74 Outstanding Visit Report Approvals (Study-Region) (Report CDA-CO-831)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

- Site Visit Metrics

# Days Visit Report Approval Outstanding

"- Site Visit Metrics"."# Days Visit Report Approval Outstanding"

- Site Visit Metrics

Indicator

CASE when ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1)>20 THEN '1-Red' WHEN (ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1) >=10 and ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding" , 1)<= 20 )THEN '2-Yellow' WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Approval Outstanding", 1) < 10 THEN '3-Green' ELSE '3-Green' END

Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

Lists all monitoring reports awaiting approval at the study-site. This report indicates which monitoring reports require an action: review and approval.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Report Approvals (Study-Site) report.

Table A-75 Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

Site Visit Report Completed Date

Site Visit.Site Visit Report Completed Date

NA

# Days Visit Report Approval Outstanding

Site Visit Metrics.# Days Visit Report Approval Outstanding

NA

Indicator

CASE when - Site Visit Metrics.# Days Visit Report Approval Outstanding>20 THEN '1-Red' WHEN - Site Visit Metrics.# Days Visit Report Approval Outstanding between 11 and 20 THEN '2-Yellow' ELSE '3-Green' END

Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

Lists all monitoring reports awaiting completion. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, CRA Overview page

Dimensions

  • Study-Site

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Reports (CRA View) report.

Table A-76 Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Completion Outstanding

Site Visit Metrics.# Days Visit Report Completion Outstanding

NA

Indicator

TBD

Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)

Lists all monitoring reports awaiting completion at the study region. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

  • Region Manager Study Manager CRA

Report Type

  • Table

Location

  • Study-Region Overview dashboard, Monitoring Reports and Follow Up Items page

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-77 describes the columns in the Outstanding Visit Reports (Study-Region View) analysis

Table A-77 Outstanding Visit Reports (Study-Region View) (Report CDA-CO-830)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Study-Site

CRA

"Study-Site"."CRA"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

- Site Visit Metrics

# Days Visit Report Completion Outstanding

"- Site Visit Metrics"."# Days Visit Report Completion Outstanding"

- Site Visit Metrics

Indicator

CASE WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding", 1)>20 THEN '1-Red' WHEN (ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding" , 1)>= 10 and ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding" , 1)<= 20) THEN '2-Yellow' WHEN ROUND("- Site Visit Metrics"."# Days Visit Report Completion Outstanding", 1) <10 then '3-Green' else '3-Green' END

Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

Lists all monitoring reports awaiting completion at the study-site. This report indicates which monitoring reports need to be completed and submitted for approval.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Visit Reports and Follow up Items page

Dimensions

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Outstanding Monitoring Reports (Study-Site View) report.

Table A-78 Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Site Visit Type

Site Visit.Site Visit Type

NA

Site Visit Start Date

Site Visit.Site Visit Start Date

NA

Site Visit Completed Date

Site Visit.Site Visit Completed Date

NA

# Days Visit Report Completion Outstanding

Site Visit Metrics.# Days Visit Report Completion Outstanding

NA

Indicator

CASE WHEN - Site Visit Metrics.# Days Visit Report Completion Outstanding >20 THEN '1-Red' WHEN - Site Visit Metrics.# Days Visit Report Completion Outstanding between 10 and 20 THEN '2-Yellow' ELSE '3-Green' END

Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

Lists all completed site visits that don't have completed visit reports, where the number of days since Site Visit Completed is within 5 days of meeting overall target. This report indicates which outstanding reports are at risk of missing the overall target.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-79 describes the columns in the Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed analysis

Table A-79 Outstanding Reports at Risk of Missing Target: Visit Completed to Visit Report Completed (Report CDA-CO-824)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

- Site Visit Metrics

# Days from Site Visit Start to Site Visit Completed

"- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" - 5) THEN 1 ELSE 0 END

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) >=("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" - 5) THEN 1 ELSE 0 END

Outstanding Reports that Missed Target - Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

Lists all completed site visits that don't have completed visit reports, where the number of days since Site Visit Completed is greater than the overall target. This report indicates which outstanding reports have already missed the overall target.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Site, Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-80 describes the columns in the Outstanding Reports that Missed Target: Site Visit Completed to Visit Report Completed analysis

Table A-80 Outstanding Reports that Missed Target: Site Visit Completed to Visit Report Completed (Report CDA-CO-827)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study Region

"Study-Site"."Study Region"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

Study-Site

Study-Site Status

"Study-Site"."Study-Site Status"

Site Visit

Site Visit Name

"Site Visit"."Site Visit Name"

Site Visit

Site Visit Type

"Site Visit"."Site Visit Type"

Site Visit

Site Visit Start Date

"Site Visit"."Site Visit Start Date"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Site Visit Completed Date

TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY"))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

"Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]"

Site Visit

Site Visit Completed Date

"Site Visit"."Site Visit Completed Date"

Site Visit

Days Since Completed

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CASE WHEN TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF(CURRENT_DAY)) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END

Site Visit

Site Visit Report Completed Date

"Site Visit"."Site Visit Report Completed Date"

Pages Awaiting Entry Completion (Report CDA-DM-450)

Identifies specific subjects who have CRFs awaiting processing. This report indicates those subjects which require processing, and the number of CRFs to be processed. This information can be used as a summary work log to drive activity.

Audience

  • Data Entry Manager

  • Data Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - Paper dashboard, Home page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Pages Awaiting Entry Completion report.

Table A-81 Pages Awaiting Entry Completion (Report CDA-DM-450)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

Paper Processing - Longest Cycle Times (Report CDA-DM-415)

Identifies the cycle times from subject visit to entry completion. This report displays the top studies with the longest cycle times for paper processing. This information can be used to highlight process inefficiencies and potential resource shortfalls.

Audience

  • Data Manager

Report Type

  • Graph, table (optional)

Location

  • Data Manager - Paper dashboard, Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Paper Processing - Longest Cycle Times report.

Table A-82 Paper Processing - Longest Cycle Times (Report CDA-DM-415)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Study Name

Received CRFs

Avg # Days from First Entry to Second Entry Complete

Received CRFs.Avg # Days from pCRF First Entry to Second Entry Complete

Received CRFs

Avg # Days from Visit to First Entry

Received CRFs.Avg # Days from pCRF Visit to First Entry

Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)

Displays a summary of site visit performance metrics for monitoring report completion and approval cycle times. For completed cycles, it displays the number and percentage of missed targets. For cycles that have not yet completed, it displays the number and percentage of missed targets and those at risk of missing a target. This report includes hyperlinks to related lists of monitoring reports.

Audience

  • Region Manager Study Manager

Report Type

  • Narrative

Location

  • Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

  • Site Visit

Supplementary Prompts

  • NA

Reports Referencing This Report

None

Column Descriptions

Table A-83 describes the columns in the Performance Metrics Summary Narrative: Site Visit analysis

Table A-83 Performance Metrics Summary Narrative: Site Visit (Report CDA-CO-1110)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Study-Site Metrics

# Completed Visits

"- Study-Site Metrics"."# Completed Site Visits"

- Site Visit Metrics

# Visit Reports that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

Overall Level Targets

# Visit Reports that Missed Target (%)

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

- Study-Site Metrics

# Completed Visits Awaiting Monitoring Report

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Site Visit Metrics

# Visits that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed" > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)/("- Study-Site Metrics"."# Visit Reports")* 100

Site Visit

# Visits at Risk of Missing Target

SUM(CASE WHEN "Site Visit"."Site Visit Completed Date" IS NOT NULL AND "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Completed Date",VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]" THEN 1 ELSE 0 END)

Site Visit

# Visits with Monitoring Report Approved

FILTER("- Study-Site Metrics"."# Visit Reports" USING ("Site Visit"."[Site Visit Report Approved Date]" IS NOT NULL))

- Site Visit Metrics

# Visits that Missed Target

SUM(CASE WHEN "- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]" > "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)

- Study-Site Metrics

# Completed Reports Awaiting Approval

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

Site Visit

# Visits that Missed Target

SUM(CASE WHEN "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND "Site Visit"."[Site Visit Report Approved Date]" IS NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)/ "- Study-Site Metrics"."[# Visit Reports Awaiting Approval]" * 100

Site Visit

# Visits at Risk of Missing Target

SUM(CASE WHEN "Site Visit"."Site Visit Report Completed Date" IS NOT NULL AND "Site Visit"."[Site Visit Report Approved Date]" IS NULL AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) >= ("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]"-5) AND TIMESTAMPDIFF(SQL_TSI_DAY,"Site Visit"."Site Visit Report Completed Date",VALUEOF("CURRENT_DAY")) <= "Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]" THEN 1 ELSE 0 END)/"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]" * 100

Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)

Displays the pie chart with the number of Study-Site related Protocol Deviations for a Study, by category.

Audience

  • Study Manager

  • CRA

Report Type

  • Pie Chart

  • Table

Location

  • Study Overview dashboard, Protocol Deviations page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Protocol Deviations (Subject) by Category (Report CDA-CO-1302)

Displays the pie chart with the number of Subject related Protocol Deviations for a Study, by category.

Audience

  • Study Manager

  • CRA

Report Type

  • Pie Chart

  • Table

Location

  • Study Overview dashboard, Protocol Deviations page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Protocol Deviations (Study-Site) Tile (Report CDA-CO-1303)

Displays the tile with the number of Study-Site related Protocol Deviations for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Study Overview dashboard, Protocol Deviations page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Protocol Deviations (Subject) Tile (Report CDA-CO-1304)

Displays the tile with the number of Subject related Protocol Deviations for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Study Overview dashboard, Protocol Deviations page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)

Lists the number of times a Study-Site has had either a Study-Site or Subject related Protocol Deviation for a particular Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Protocol Deviations page

Dimensions

  • Study-Site

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)

Displays the details of the Study-Site related Protocol Deviations for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview - Protocol Deviations dashboard

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Deviation (Subject) Details (Report CDA-CO-1307)

Displays the details of Subject related Protocol Deviations for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview - Protocol Deviations dashboard

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Protocol Versions (Report CDA-CO-115)

Lists details for the different versions of a protocol, including approved date, version number and comments.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • List

Location

  • Not included on a dashboard

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

Screen Failure Reason (Report CDA-CO-420)

Displays number screen failures for a study-site, by screen failure reason. This report indicates the distribution of screen failure reasons among subjects who failed screening.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

  • Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason report.

Table A-84 Screen Failure Reason (Report CDA-CO-420)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Screen Failure Reason

Subject.Screen Failure Reason

NA

Count of Screen Failure Reasons

COUNT(Subject.Screen Failure Reason)

Screen Failure Reason (Report CDA-CO-425)

Displays (by screen failure reason) the number of subjects who failed screening. This report indicates which screen failure reasons account for the most screen failures.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Screening Overview page

  • Study-Region Overview dashboard, Screening Overview page

Dimensions

  • Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason report.

Table A-85 Screen Failure Reason (Report CDA-CO-425)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Subject

Screen Failure Reason

Subject.Screen Failure Reason

NA

Subject Status

COUNT(- Subject Metrics.Subject Status)

Screen Failure Reason by Site (Report CDA-CO-300)

Displays (by site) the number of subjects who failed screening. This report indicates which screen failure reasons account for the most screen failures.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Screening Overview page

  • Study Region Overview dashboard, Screening Overview page

Dimensions

  • Subject

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screen Failure Reason by Site report.

Table A-86 Screen Failure Reason by Site (Report CDA-CO-300)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Subject Status

COUNT(- Subject Metrics.Subject Status)

Subject

Screen Failure Reason

Subject.Screen Failure Reason

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

Screening Overview (Study Level) (Report CDA-CO-407)

Displays a summary of screening information for a study. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study Overview dashboard, Screening Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening Overview (Study Level) report.

Table A-87 Screening Overview (Study Level) (Report CDA-CO-407)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Screened

Study-Site Metrics.# Screened

NA

# Re-Screened

Study-Site Metrics.# Re-Screened

NA

# Screen Failure

Study-site Metrics.# Screen Failure

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% Enrolled / Planned

Study Metrics.% Enrolled / Planned in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized / Planned

Study Metrics.% Randomized vs. Planned Study

Screening Overview (Study-Region Level) (Report CDA-CO-434)

Displays a summary of screening information for a study. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study.

Audience

  • Region Manager

Report Type

  • Narrative

Location

  • Study-Region Overview dashboard, Screening Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-88 describes the columns in the Screening Overview (Study-Region Level) analysis

Table A-88 Screening Overview (Study-Region Level) (Report CDA-CO-434)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Screened

"- Study-Site Metrics"."# Screened"

- Study-Site Metrics

# Re-Screened

"- Study-Site Metrics"."# Re-Screened"

- Study-Site Metrics

# Screen Failure

"- Study-site Metrics"."# Screen Failure"

- Study-Site Metrics

# Enrolled

"- Study-site Metrics"."# Enrolled"

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study-Site Metrics

# Randomized

"- Study-site Metrics"."# Randomized"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

Screening Overview (Study-Site Level) (Report CDA-CO-415)

Displays a summary of screening information for a study-site. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Screening and Recruitment Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening Overview (Study-Site Level) report.

Table A-89 Screening Overview (Study-Site Level) (Report CDA-CO-415)

Table Heading Column Heading Measure or Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Screened

Study-site Metrics.# Screened

NA

# Re-Screened

Study-site Metrics.# Re-Screened

NA

# Screen Failure

Study-site Metrics.# Screen Failure

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

NA

% of Total Enrolled in Study

Study-site Metrics.% of Total Enrolled in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized / Planned - Study

Study Metrics.% Randomized vs. Planned - Study

NA

% of Total Randomized in Study

Study-site Metrics.% of Total Randomized in Study

Screening vs. Enrollment by Region (Report CDA-CO-400)

Displays cumulative screening and enrollment by study region. This report indicates how each region in a study is progressing toward recruitment goals.

Audience

  • Study Manager

  • CRA

  • Region Manager

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Screening Overview page

  • Study Region Overview dashboard, Screening Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Screening vs. Enrollment by Region report.

Table A-90 Screening vs. Enrollment by Region (Report CDA-CO-400)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Screened

Study-site Metrics.# Screened

Site Detail (Report CDA-CO-209)

Lists (by program, study, and region) site details, including status, and first subject screened, enrolled and randomized dates. This report indicates the progress of site selection and number of sites ready to enroll. It also indicates the sites and investigators selected.

Audience

  • Study Manager

  • CRA

Report Type

  • Pivot Table

Location

None

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

The table describes the columns in the Site Detail report.

Table A-91 Site Detail (Report CDA-CO-209)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Program

Study-Site.Program

NA

Product Name

Study-Site.Product Name

NA

Study

Study-Site.Study

NA

Study Status

Study.Study Status

NA

Study Region

Study-Site.Study Region

NA

Region Status

Region.Region Status

NA

Site Name

Study-Site.Site Name

NA

Principal Investigator

Study-Site.Principal Investigator

NA

CRA

Study-Site.CRA

NA

Study-Site Status

Study-Site.Study-Site Status

NA

First Subject Screened Date

Study-Site Metrics.First Subject Screened Date

NA

First Subject Enrolled Date

Study-Site Metrics.First Subject Enrolled Date

NA

First Subject Randomized Date

Study-Site Metrics.First Subject Randomized Date

NA

# Subjects Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Screened

Study-site Metrics.# Screened

NA

# Re-Screened

Study-site Metrics.# Re-Screened

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Randomized

Study-site Metrics.# Randomized

Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

Provides a scatter plot displaying the number of completed site visits for a study-site compared to the study-site's contribution to the total enrollment for the study (% of Total Enrolled in Study). This report helps to identify which study-sites provide the most enrollment value for the least monitoring effort and vice versa.

Audience

  • Study Manager

Report Type

  • Scatter Plot

Location

  • Study Overview dashboard, Site Performance page

Dimensions

  • Study-Site

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-92 describes the columns in the Site Enrollment Performance Compared to Site Visit Frequency analysis

Table A-92 Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

"Study-Site"."Study"

Study-Site

Study-Site ID #

"Study-Site"."Study-Site ID #"

Study-Site

Principal Investigator

"Study-Site"."Principal Investigator"

- Study-Site Metrics

% of Total Enrolled in Study

"- Study-Site Metrics"."% of Total Enrolled in Study"

- Study-Site Metrics

# Completed Site Visits

"- Study-Site Metrics"."# Completed Site Visits"

Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

Line-bar graph that shows the number of sites initiated compared to the number of sites planned for a Study-Region.

Audience

  • Region Manager, Study Manager, Executive Manager, Program Manager

Report Type

  • View Selector (Chart, Table)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • All Purpose Date

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-93 describes the columns in the Site Initiation Over Time Bar Chart (Study Region) analysis

Table A-93 Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

- Study Region Metrics

# Study-Sites Planned for Study-Region

"- Study Region Metrics"."# Study-Sites Planned for Study-Region"

- Study Region Metrics

# Study-Sites Initiated

"- Study Region Metrics"."# Study-Sites Initiated"

Site Recruitment Performance - Single Study (Report CDA-CO-416)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, or greater than 90% of planned enrollment completed, by region. Each bar displays the number of sites, and the line displays the percentage of sites. This report indicates how many sites are performing well or poorly with regard to subject recruitment.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Site Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Recruitment Performance - Single Study report.

Table A-94 Site Recruitment Performance - Single Study (Report CDA-CO-416)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Study-Sites

Study Metrics.# Study-Sites

NA

# Study-Sites with 1 or more Subjects Enrolled

Study Metrics.# Study-Sites with 1 or more Subjects Enrolled

NA

# Study-Sites with no Subjects Enrolled

Study Metrics.# Study-Sites - - Study Metrics.# Study-Sites with 1 or more Subjects Enrolled

NA

# Study-Sites Recruiting > 90% Planned Subjects

SUM(CASE WHEN - Study-site Metrics.% Enrolled to Total Planned at Study-Site>90.00 THEN 1 END BY Study-Site.Study Region)

NA

% with 1 or more Subjects Enrolled

((- Study Metrics.# Study-Sites with 1 or more Subjects Enrolled) *100) / (- Study Metrics.# Study-Sites)

NA

% with no Subjects Enrolled

((- Study Metrics.# Study-Sites - - Study Metrics.# Study-Sites with 1 or more Subjects Enrolled) *100) / (- Study Metrics.# Study-Sites)

NA

% Study-Sites Recruiting > 90% Planned Subjects

(SUM(CASE WHEN - Study-site Metrics.% Enrolled to Total Planned at Study-Site>90 THEN 1 END BY Study-Site.Study Region)*100)/- Study Metrics.# Study-Sites

Site Recruitment Performance (Report CDA-CO-413)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, greater than 90% of planned enrollment completed, or enrolling more than 1 subject but less than 90% of planned enrollment. This report indicates the distribution of top performing and non-performing study-sites.

Audience

  • Executive

  • Region Manager

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Site Performance page

  • Executive dashboard, Site Recruitment Performance Summary page

  • Study-Region Overview dashboard, Site Performance page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Recruitment Performance report.

Table A-95 Site Recruitment Performance (Report CDA-CO-413)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Category

TBD

NA

Study-Site ID #

Study-Site.Study-Site ID #

Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

Shows the study-sites with 1 or more subjects enrolled, no subjects enrolled, or greater than 90% of planned enrollment completed, by program. Each bar displays the number of sites, and the line displays the percentage of sites. This report indicates how many sites are performing well or poorly with regard to subject recruitment.

Audience

  • Region Manager

Report Type

  • View Selector (Chart, Table)

Location

  • Executive dashboard, Site Recruitment Performance Summary page

Dimensions

  • Study-Site

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-96 describes the columns in the Site Recruitment Performance Charts (Executive View) analysis

Table A-96 Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Program

NA

Study Metrics

# Study-Sites

NA

Study Metrics

# Study-Sites with 1 or more Subjects Enrolled

NA

Study Metrics

# Sites Recruiting 0 Subjects

NA

Study Metrics

# Sites Recruiting at Least 90% of Planned Subjects

NA

Study Metrics

% Sites Recruiting 0 Subjects

NA

Study Metrics

% Sites Recruiting 1 or More Subjects

NA

Study Metrics

% Sites Recruiting at Least 90% of Planned Subjects

NA

Site Visit Analysis (Report CDA-CO-821)

Shows the number of site visits and median days form site visit start to site visit completed, over time. This report indicates the relationship between site visit duration and the number of site visits completed.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Monitoring Metrics page

Dimensions

  • All-Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Analysis report.

Table A-97 Site Visit Analysis (Report CDA-CO-821)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Site Visits

Study-site Metrics.# Site Visits

NA

Median # Days from Site Visit Start to Site Visit Completed

MEDIAN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

Site Visit Duration - Study (Report CDA-CO-808)

Displays the median duration of site visits that have taken place across all study-sites for this study, as well as the total number of completed site visits. This report indicates the median amount of time it might take to complete a site visit for a study.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Monitoring Metrics page

  • Region Manager dashboard, Visit Reports & Follow Up Items page

Dimensions

  • Site Visit

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Duration - Study report.

Table A-98 Site Visit Duration - Study (Report CDA-CO-808)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Median Site Visit Duration for Study

MEDIAN (- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Total Number Completed Site Visits for Study

COUNT (Site Visit.Site Visit Completed Date)

Site Visit Duration - Study Site (Report CDA-CO-800)

Displays the minimum, median, and maximum duration of site visits that have taken place at this study-site, as well as the total number of completed site visits. This report indicates the amount of time it might take to complete a site visit for a study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Site Visit Duration - Study Site report.

Table A-99 Site Visit Duration - Study Site (Report CDA-CO-800)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Min Site Visit Duration

MIN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Median Site Visit Duration

MEDIAN(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Max Site Visit Duration

MAX(- Site Visit Metrics.# Days from Site Visit Start to Site Visit Completed)

NA

Total Number Completed Site Visits for Study-Site

COUNT (Site Visit.Site Visit Completed Date)

Site Visit Duration - Study-Region (Report CDA-CO-829)

Displays the minimum, median, and maximum duration of site visits that have taken place in this study-region, as well as the total number of completed site visits. This report indicates the amount of time it might take to complete a site visit for a study-site in this study-region.

Audience

  • Region Manager

Report Type

  • Narrative

Location

  • Study-Region Overview dashboard, Visit Reports and Follow Up Items page

Dimensions

  • Site Visit

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-100 describes the columns in the Site Visit Duration - Study-Region analysis.

Table A-100 Site Visit Duration - Study-Region (Report CDA-CO-829)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- Site Visit Metrics

Min Site Visit Duration

MIN("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

- Site Visit Metrics

Median Site Visit Duration

MEDIAN("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

- Site Visit Metrics

Max Site Visit Duration

MAX("- Site Visit Metrics"."# Days from Site Visit Start to Site Visit Completed")

Site Visit

Total Number Completed Site Visits for Study-Region

COUNT("Site Visit"."Site Visit Completed Date")

Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and recruitment details. This report indicates which sites might need to be monitored.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Recruitment Detail View report.

Table A-101 Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

"- Study-Site Metrics"."% Randomized vs. Planned - Study-Site"

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

NA

Navigate to detail

NA

Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and retention details. This report indicates which sites might need to be monitored.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Retention Detail View report.

Table A-102 Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

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Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and retention details. This report indicates which sites might need to be monitored.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Study Close Detail View report.

Table A-103 Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

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Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

Lists study-sites, sorted by the number of days that have passed since the last site visit. Includes planned and actual milestones and monitoring details. This report indicates which sites might need to be monitored.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites to Monitor - Days Since Last Visit - Summary View report.

Table A-104 Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

# Days Since Latest Site Visit

"- Study-Site Metrics"."# Days Since Latest Site Visit"

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

NA

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NA

Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject recruitment information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation and whether they have screened or enrolled subjects.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Recruitment Detail View report.

Table A-105 Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Planned:',cast(MAX(ROUND("- Study Targets"."[Expected Screen Failure Rate]", 2)) as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."Screen Failure Rate", 2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

"- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site"

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

"- Study-Site Metrics"."% Randomized vs. Planned - Study-Site"

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]" as char(40))))||'<br/>'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study-Site Metrics"."1st Subject Screened Date" , 'dd-Mon-yyyy'))

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

NA

Navigate to Detail

NA

Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject retention information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation and whether they have randomized or enrolled subjects.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Retention Detail View report.

Table A-106 Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Study-Site Metrics

Milestone Indicator

"- Study-Site Metrics"."Milestone Indicator"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('LE:',MIN(cast("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'<br/>'||CONCAT('Actual Latest:',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual Last:',cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',MIN(cast(ROUND("- Study-Site Study-Site Targets"."Expected Early Termination Rate", 2) as char(40))))||'<br/>'||CONCAT('Actual:' , cast(ROUND( "- Study-Site Metrics"."% Subjects Early Terminated for Study-Site", 2) as char(40)))

Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

Lists study-sites that have been initiated, but that have not yet had an interim monitoring visit. Includes subject recruitment information. This report indicates which sites might need to be monitored by identifying initiated sites that have not had an interim monitoring visit since initiation, and whether they have enrolled subjects.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Sites to Monitor page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Sites with No Visits Since Initiation - Summary View report.

Table A-107 Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Study-Site Metrics

# Days Since Latest Site Visit

"- Study-Site Metrics"."# Days Since Latest Site Visit"

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

NA

Navigate to Detail

NA

Study Documents List (Report CDA-CO-600)

Lists all study documents collected, including document status, sent date, received date, and comments. This report indicates which study-level documents have been collected or are missing.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study Document List page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Documents List report.

Table A-108 Study Documents List (Report CDA-CO-600)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Activity Type

Document Metrics.Activity Type

NA

Document Name

Document Metrics.Document Name

NA

Document Sent Date

Document Metrics.Document Sent Date

NA

Document Received Date

Document Metrics.Document Received Date

NA

Document Expiration Date

Document Metrics.Document Expiration Date

NA

Document Comments

Document Metrics.Document Comments

NA

Document Expiration Date Indicator

TBD

Study Enrollment Progress Gauge (Report CDA-CO-445)

Displays a gauge showing how many subjects have been enrolled in the study compared to the number of subjects planned for the study.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study Information (Report CDA-CO-103)

Displays a summary of identifying information for a study, including Study #, Program, Product and Study Status.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study Overview dashboard, Study Overview page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Information report.

Table A-109 Study Information (Report CDA-CO-103)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study.Study

NA

Program

Study.Program

NA

Product

Study.Product

NA

Short Title

Study.Study Short Title

NA

Status

Study.Study Status

NA

Phase

Study.Study Phase

NA

Study Manager

Study.Study Manager

Study List - Initiation Details (Report CDA-CO-305)

Lists studies that are not in a status of Completed or Planned and have not achieved 100% enrollment. Displays planned and actual number of sites, including how many are initiated, screening, and enrolling. This report provides a list of ongoing studies that have not yet achieved 100% enrollment, including number of study-sites to reach certain achievements.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Initiating and Recruiting Studies page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study List - Initiation Details report.

Table A-110 Study List - Initiation Details (Report CDA-CO-305)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Program

Study.Program

Study

Study

Study.Study

Study

Status

Study.Study Status

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

Study Metrics, Counts

# Study-Sites Planned for Study

NA

Study Metrics, Counts

# Study-Sites Initiated

NA

Study Metrics, Counts

# Sites with 1 or More Subjects Screened

NA

Study Metrics, Counts

# Study-Sites with 1 or more Subjects Enrolled

NA

Study Metrics, Ratios

% of Planned Sites Initiated

NA

Study, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study Metrics, Actual Milestones

1st Site Initiated Date

NA

Study, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study Metrics, Actual Milestones

Latest Site Initiated Date

NA

Study Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

NA

Navigate to Detail

NA

Study List - KPI Performance (Report CDA-CO-904)

Provides a list of studies with target/actual KPIs and a KPI indicator. This report indicates whether a study is performing within target range for KPIs.

Audience

  • Executive

Report Type

  • Table (View Selector)

Location

None

Dimensions

  • Study

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

You can navigate to the following reports from this report:

Column Descriptions

Table A-111 describes the columns in the Study List: KPI Performance analysis

Table A-111 Study List: KPI Performance (Report CDA-CO-904)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Status

"Study"."Study Status"

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

KPI Indicator

"- Study Metrics"."KPI Indicator"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."% Sites Recruiting 0 Subjects", 2) as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Metrics"."% Sites Recruiting 0 Subjects", 2) as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' ,MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' ,MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]", 2) as char(40))))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)", 2) as char(40))))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)", 2) as char(40))))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]", 2) as char(40))))

- Site Visit Metrics

[# Days from Visit Report Completed to Visit Report Approved]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:',MIN(cast(ROUND("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]", 2) as char(40))))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)", 2) as char(40))))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)", 2) as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]", 2) as char(40))))

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]", 2) as char(40))))

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40)))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40)))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))

- Study Metrics

[Last Subject Last Visit to Database Lock (# Days)]

CONCAT('Overall Target:',MIN(cast(ROUND("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))||'

'||CONCAT('Actual:' , MIN(cast(ROUND("- Study Metrics"."[Last Subject Last Visit to Database Lock (# Days)]", 2) as char(40))))

- Study Original Planned Dates

[Planned Database Lock Date]

MIN("- Study Original Planned Dates"."[Planned Database Lock Date]")

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned Database Lock Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]" as char(40))))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',MIN(cast("- Study Original Planned Dates"."[Planned Database Lock Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]" as char(40))))

- Study Metrics

1st Site Initiated Date

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Site Initiated Date

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CASE WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Site Initiated Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Site Initiated Date

"- Study Metrics"."1st Site Initiated Date"

- Study Metrics

1st Subject Enrolled Date

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Subject Enrolled Date

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

[Protocol Approved Date]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CASE WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > "Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") THEN 'RED' WHEN ("- Study Metrics"."1st Subject Enrolled Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Key Dates"."[Protocol Approved Date]", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

Database Lock Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

Last Subject Last Visit Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Key Dates

Database Lock Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

Last Subject Last Visit Date

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CASE WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > "- Study Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") THEN 'RED' WHEN ("- Study Key Dates"."Database Lock Date" IS NULL) AND (TIMESTAMPDIFF(SQL_TSI_DAY,"- Study Metrics"."Last Subject Last Visit Date", VALUEOF("CURRENT_DAY")) > ("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"-30)) THEN 'YELLOW' END

- Study Metrics

1st Subject Enrolled Date

"- Study Metrics"."1st Subject Enrolled Date"

- Study Metrics

[Last Subject Last Visit Date]

"- Study Metrics"."[Last Subject Last Visit Date]"

- Study Key Dates

[Protocol Approved Date]

MIN("- Study Key Dates"."[Protocol Approved Date]")

- Study Key Dates

Database Lock Date

MIN("- Study Key Dates"."Database Lock Date")

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]"

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

"Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]"

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

"Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]"

Study List - Milestone Performance (Report CDA-CO-109)

Provides a list of studies with planned, latest estimate and actual milestones, and a milestone indicator. This report indicates whether a study has exceeding planned dates for outstanding milestones.

Audience

  • Study Manager

Report Type

  • Table

Location

None

Dimensions

  • Study

Supplementary Prompts

  • NA

Reports Referencing This Report

You can navigate from the following reports to this report:

Column Descriptions

Table A-112 describes the columns in the Study List: Milestone Performance analysis

Table A-112 Study List: Milestone Performance (Report CDA-CO-109)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study

Study Status

"Study"."Study Status"

Study

Study Manager

"Study"."Study Manager"

- Study Region Metrics

Milestone Flag

"- Study Region Metrics"."Milestone Flag"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'|| CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Metrics"."[1st IRB/EC Submission Date]" , 'dd-Mon-yyyy'))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Latestt):',cast( "- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast( "- Study Metrics"."[Last Subject Last Visit Date]"as char(40)))

Study List - Recruitment Details (Report CDA-CO-406)

Lists studies that are not in a status of Completed or Planned and have not achieved 100% enrollment. Displays planned and actual recruitment information. This report provides a list of ongoing studies that have not yet achieved 100% enrollment, including recruitment information.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Initiating and Recruiting Studies page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study List - Recruitment Details report.

Table A-113 Study List - Recruitment Details (Report CDA-CO-406)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study

Program

Study.Program

Study

Study

Study.Study

Study

Status

Study.Study Status

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MIN(ROUND("- Study Targets"."[Expected Screen Failure Rate]",2)) as char(40)))||'<br/>'||CONCAT('Actual:',cast(ROUND("- Study Metrics"."Screen Failure Rate",2) as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MIN(ROUND("- Study Targets"."[Expected Screen Failure Rate]",2)) as char(40)))||'<br/>'||CONCAT('Actual:',cast(ROUND("- Study Metrics"."Screen Failure Rate",2) as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:',cast(ROUND("- Study Metrics"."% Planned Subjects Enrolled (Study)",2) as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:',cast(ROUND("- Study Metrics"."% Planned Subjects Randomized (Study)",2) as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Screened Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

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Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Lists (for a study) key milestone dates and enrollment, enrollment progress, and study-health indicator. This report indicates whether a study requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

The table describes the columns in the Study Milestone with Indicators (Study Overview) report.

Table A-114 Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Program

"Study"."Program"

Study

Study

"Study"."Study"

Study

Study Manager

"Study"."Study Manager"

- Study Metrics

Recruitment Flag

"- Study Metrics"."Recruitment Flag"

- Study Metrics

Recruitment Detail Reason

"- Study Metrics"."Recruitment Detail Reason"

- Study Metrics

Retention Flag

"- Study Metrics"."Retention Flag"

- Study Metrics

Retention Detail Reason

"- Study Metrics"."Retention Detail Reason"

- Study Metrics

Milestone Flag

"- Study Metrics"."Milestone Flag"

- Study Metrics

Milestone Detail Reason

"- Study Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('[Expected]:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

Screen Failure Rate

CONCAT('[Expected]:',cast(MIN("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."Screen Failure Rate" as char(40)))

- Study Metrics

% of Planned Sites Initiated

CONCAT('Actual:',cast("- Study Metrics"."% of Planned Sites Initiated" as char(40)))

- Study Metrics

% Planned Subjects Enrolled (Study)

CONCAT('Actual:',cast("- Study Metrics"."% Planned Subjects Enrolled (Study)" as char(40)))

- Study Targets

Expected Early Termination Rate

CONCAT('[Expected]:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."% Subjects Early Terminated for Study") as char(40)))

- Study Metrics

% Subjects Early Terminated for Study

CONCAT('[Expected]:',cast(MIN("- Study Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."% Subjects Early Terminated for Study") as char(40)))

- Study Metrics

% Planned Subjects Randomized (Study)

CONCAT('Actual:',cast("- Study Metrics"."% Planned Subjects Randomized (Study)" as char(40)))

- Study Key Dates

[Protocol Approved Date]

CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Protocol Approved Date]") as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Database Lock Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."Database Lock Date") as char(40)))

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/ "- Discrepancies"."# Total Discrepancies")

- Discrepancies (Queries)

# Total Discrepancies (Queries)

("- Discrepancies"."# Days Discrepancy Open"/ "- Discrepancies"."# Total Discrepancies")

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."1st Subject Screened Date") as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject Randomized Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Metrics

Latest Subject Enrollment Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Enrollment Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Enrolled Date]"as char(40)))

- Study Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):' , cast("- Study Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):' , cast("- Study Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast( "- Study Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Metrics

# Study-Sites Planned for Study

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Metrics

# Study-Sites Initiated

CONCAT('Planned:',cast(MIN("- Study Metrics"."# Study-Sites Planned for Study") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Metrics"."# Study-Sites Initiated") as char(40)))

- Study Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."1st Site Initiated Date" as char(40)))

- Study Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Latestl:',cast("- Study Metrics"."Latest Site Initiated Date" as char(40)))||'<br/>'||CONCAT('Last:',cast("- Study Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MIN("- Study Original Planned Dates"."[Planned Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Study Metrics

KPI Flag

"- Study Metrics"."KPI Flag"

- Study Metrics

KPI Detail Reason

"- Study Metrics"."KPI Detail Reason"

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:' ,cast(MAX("- Study Metrics"."% Sites Recruiting 0 Subjects") as char(40)))

- Study Metrics

% Sites Recruiting 0 Subjects

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Expected % Sites Recruiting 0 Subjects]") as char(40)))||'<br/>'||CONCAT('Actual:' ,cast(MAX("- Study Metrics"."% Sites Recruiting 0 Subjects") as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))

- Study Metrics

[Protocol Approved to 1st Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Site Initiated (# Days)]") as char(40)))

Overall Level Targets

[Target Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))

- Study Metrics

[Protocol Approved to 1st Subject Enrolled (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Protocol Approved to 1st Subject Enrolled (# Days)]") as char(40)))

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))

- Study Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."[Median Critical Document Package Complete to Site Initiated (# Days)]") as char(40)))

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)") as char(40)))

- Study Metrics

Median Site Visit Completed to Visit Report Completed (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Site Visit Completed to Visit Report Completed (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Site Visit Completed to Visit Report Completed (# Days)") as char(40)))

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)") as char(40)))

- Study Metrics

Median Visit Report Completed to Visit Report Approved (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Visit Report Completed to Visit Report Approved (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Median Visit Report Completed to Visit Report Approved (# Days)") as char(40)))

Overall Level Targets

[Target Last Subject Last Visit to Database Lock (# Days)]

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)") as char(40)))

- Study Metrics

Latest Subject Latest Visit to Database Lock (# Days)

CONCAT('[Overall Target]:',cast(MAX("Overall Level Targets"."[Target Last Subject Last Visit to Database Lock (# Days)]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study Metrics"."Latest Subject Latest Visit to Database Lock (# Days)") as char(40)))

Study RACT (Report CDA-CO-852)

Displays the RACT (Risk Assessment Categorization Tool) for a Study. This analysis lists all the questions on the RACT with the scores for impact, probability, and detectability. It also lists any considerations, mitigations, or comments.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Not included on a dashboard

Dimensions

  • Study

  • RACT Category

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study RACT by Category (Report CDA-CO-853)

Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Not included on a dashboard

Dimensions

  • Study

  • RACT Category

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

Study RACT Score Tile (Report CDA-CO-858)

Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-115 describes the columns in the Study Region Milestones with Indicators - Data Management View analysis.

Table A-115 Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# TotalDiscrepancies")

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"�

Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-116 describes the columns in the Study Region Milestones with Indicators - Recruitment Detail View analysis.

Table A-116 Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-117 describes the columns in the Study Region Milestones with Indicators - Retention Detail View analysis.

Table A-117 Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-118 describes the columns in the Study Region Milestones with Indicators - Site Start Up Detail View analysis.

Table A-118 Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-119 describes the columns in the Study Region Milestones with Indicators - Study Close Detail View analysis.

Table A-119 Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

A list of study-regions including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates which study-regions require action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Region Manager dashboard, Study-Region Milestones and Schedule page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-120 describes the columns in the Study Region Milestones with Indicators - Summary View analysis.

Table A-120 Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-RegionStatus"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study Key Dates

[Protocol Approved Date]

max("- Study KeyDates"."[Protocol ApprovedDate]")

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Data Management View analysis.

Table A-121 Study Region Milestones with Indicators (Single Study-Region) - Data Management View (Report CDA-CO-1116A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

Discrepancies (Queries)

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/"-Discrepancies"."# TotalDiscrepancies")

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-122 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View analysis.

Table A-122 Study Region Milestones with Indicators (Single Study-Region) - Recruitment Detail View (Report CDA-CO-1116B)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View analysis.

Table A-123 Study Region Milestones with Indicators (Single Study-Region) - Retention Detail View (Report CDA-CO-1116C)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-124 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View analysis.

Table A-124 Study Region Milestones with Indicators (Single Study-Region) - Site Start Up Detail View (Report CDA-CO-1116D)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-121 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View analysis.

Table A-125 Study Region Milestones with Indicators (Single Study-Region) - Study Close Detail View (Report CDA-CO-1116E)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

Lists (for a study-region) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, data management, and study close. Includes study-region-health indicators for recruitment, retention, milestones and KPIs. This report indicates whether a study-region requires action, and why.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • View Selector (Multiple Tables)

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-126 describes the columns in the Study Region Milestones with Indicators (Single Study-Region) - Summary View analysis.

Table A-126 Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study Key Dates

[Protocol Approved Date]

max("- Study KeyDates"."[Protocol ApprovedDate]")

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)

Line bar chart with bar for each study-region reflecting value for each study region and a point for study median. Column selector for each of the following metrics:

  • Initial IRB/EC Approval to Site Initiated (# Days)

  • Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

  • Site Initiated to 1st Subject Enrolled (# Days)

Audience

  • Region Manager

  • Study Manager

Report Type

  • View Selector (Line Graph)

Location

  • Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-127 describes the columns in the Study Region vs. Study: Site Start Up KPIs analysis

Table A-127 Study Region vs. Study: Site Start Up KPIs (Report CDA-CO-1111)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Metrics

1st Site Initiated to 1st Subject Enrolled (# Days)

"- Study Metrics"."1st Site Initiated to 1st Subject Enrolled (# Days)"

- Study Region Metrics

1st Site Initiated to 1st Subject Enrolled (# Days)

MEDIAN("- Study Region Metrics"."1st Site Initiated to 1st Subject Enrolled (# Days)")

- Study Metrics

1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

"- Study Metrics"."1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)"

- Study Region Metrics

1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)

MEDIAN("- Study Region Metrics"."1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)")

- Study Metrics

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

"- Study Metrics"."1st Initial IRB/EC Approval to 1st Site Initiated (# Days)"

- Study Region Metrics

1st Initial IRB/EC Approval to 1st Site Initiated (# Days)

MEDIAN("- Study Region Metrics"."1st Initial IRB/EC Approval to 1st Site Initiated (# Days)")

Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-128 describes the columns in the Study Regions with Red or Yellow Performance Flag - Data Management Detail View analysis.

Table A-128 Study Regions with Red or Yellow Performance Flag - Data Management Detail View (Report CDA-CO-1200A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Discrepancies (Queries)

# Open Discrepancies (Queries)

NA

Discrepancies (Queries)

# Total Discrepancies (Queries)

NA

Discrepancies (Queries)

# Days Discrepancy (Query) Open

NA

Received CRFs

# CRFs Awaiting Entry Completion

NA

Received CRFs

# eCRFs To Be Approved

NA

Received CRFs

# eCRFs To be Verified

NA

Received CRFs

# CRFs Soft Locked (Frozen)

NA

Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

NA

Received CRFs

# CRFs Hard Locked (Locked)

NA

Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

NA

Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-129 describes the columns in the Study Regions with Red or Yellow Performance Flag - Recruitment Detail View analysis.

Table A-129 Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region Metrics, Ratios

% Planned Subjects Randomized

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Screened Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Screened Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject 1st Visit Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject 1st Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject 1st Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject 1st Visit Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-130 describes the columns in the Study Regions with Red or Yellow Performance Flag - Retention Detail View analysis.

Table A-130 Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Enrolled Date

NA

Study-Region, Original Planned Dates

[Planned 1st Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

1st Subject Randomized Date

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-131 describes the columns in the Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View analysis.

Table A-131 Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Counts

# Study-Sites Planned for Study-Region

NA

Study-Region Metrics, Counts

# Study-Sites Initiated

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Original Planned Dates

[Planned 1st IRB/EC Submission Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

NA

Study-Region Metrics, Actual Milestones

[1st IRB/EC Submission Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

NA

Study-Region Metrics, Actual Milestones

1st Initial IRB/EC Approval Date

NA

Study-Region, Original Planned Dates

[Planned 1st Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

NA

Study-Region Metrics, Actual Milestones

1st Site Initiated Date

NA

Study-Region, Original Planned Dates

[Planned Last Site Initiated Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Site Initiated Date]

NA

Study-Region Metrics, Actual

Latest Site Initiated Date

NA

Study-Region Metrics, Actual Milestones

[Last Site Initiated Date]

NA

Study-Region, Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[1st Critical Document Package Completed Date]

NA

Study-Region, Original Planned Dates

[Planned Last Critical Document Package Completed Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Latest Critical Document Package Completed Date]

NA

Study-Region Metrics, Actual Milestones

[Last Critical Document Package Completed Date]

NA

Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-132 describes the columns in the Study Regions with Red or Yellow Performance Flag - Study Close Detail View analysis.

Table A-132 Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study-Region, Original Planned Dates

[Planned Last Subject Enrolled Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Enrolled Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Enrolled Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Randomized Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Randomized Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Randomized Date]

NA

Study-Region, Original Planned Dates

[Planned Last Subject Last Visit Date]

NA

Study-Region, Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

NA

Study-Region Metrics, Actual Milestones

Latest Subject Latest Visit Date

NA

Study-Region Metrics, Actual Milestones

[Last Subject Last Visit Date]

NA

Received CRFs

# CRFs Awaiting Entry Completion

NA

Received CRFs

# eCRFs To Be Approved

NA

Received CRFs

# eCRFs To be Verified

NA

Received CRFs

# CRFs Soft Locked

NA

Received CRFs

% CRFs Soft Locked / Entry Complete

NA

Received CRFs

# CRFs Hard Locked

NA

Received CRFs

% CRFs Hard Locked / Entry Complete

NA

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study, Original Planned Dates

[Planned Clinical Study Report Date]

NA

Study, Latest Estimate Dates

[Planned LE Clinical Study Report Date]

NA

Study, Key Dates

[Clinical Study Report Date]

NA

Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

Lists study-regions with an indicator of study-region health, where the indicator is red or yellow. This report indicates which study-regions require action and why.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Overview page

Dimensions

None

Supplementary Prompts

NA

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-133 describes the columns in the Study Regions with Red or Yellow Performance Flag - Summary View analysis.

Table A-133 Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics, Flags

Recruitment Flag

NA

Study-Region Metrics, Flags

Recruitment Detail Reason

NA

Study-Region Metrics, Flags

Retention Flag

NA

Study-Region Metrics, Flags

Retention Detail Reason

NA

Study-Region Metrics, Flags

Milestone Flag

NA

Study-Region Metrics, Flags

Milestone Detail Reason

NA

Study-Region Metrics, Ratios

% of Planned Sites Initiated

NA

Study-Region, Study-Region Targets

[Expected Screen Failure Rate]

NA

Study-Region Metrics, Ratios

Screen Failure Rate

NA

Study-Region Metrics, Ratios

% Enrolled to Total Planned at Study-Region

NA

Study-Region

[Expected Early Termination Rate]

NA

Study-Region Metrics

% Subjects Early Terminated for Study-Region

NA

Study

[Protocol Approved Date]

NA

Study, Original Planned Dates

[Planned Database Lock Date]

NA

Study, Latest Estimate Dates

[Planned LE Database Lock Date]

NA

Study, Key Dates

Database Lock Date

NA

Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

Lists the study-sites including key CRF and discrepancy (query) metrics as well as progress tracking for site data management. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Data Management View report.

Table A-134 Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Queries) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

Lists the study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Monitoring View report.

Table A-135 Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Recruitment Detail View report.

Table A-136 Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Retention Detail View report.

Table A-137 Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Site Start Up Detail View report.

Table A-138 Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Study Close Detail View report.

Table A-139 Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

Lists the study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention, and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study Site Milestones with Indicators - Summary View report.

Table A-140 Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

Lists all study-sites that have been initiated but have not yet enrolled a subject, including the time since initiation. This report indicates how poorly a study-site is performing with regard to enrolling the first subject post-initiation.

Audience

  • Study Manager

  • CRA

  • Region Manager

Report Type

  • Table

Location

  • Study Overview dashboard, Non Performing Investigators page

  • Study Region Overview dashboard, Non-Performing Investigators page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Sites Initiated but Zero Enrolled report.

Table A-141 Study Sites Initiated but Zero Enrolled (Report CDA-CO-301)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

Study-Region

Region Name

Study-Region.Region Name

Site Initiated

Date

Study-Site.Site Initiated Date

Site Initiated

Days Since

Study-site Metrics.Days Since Initiation

NA

Navigate to Detail

NA

Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Lists all study-sites that have been initiated but have only enrolled one subject, including the time since that subject was enrolled. This report indicates how poorly a study-site is performing with regard to enrolling more than one subject post-initiation.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Non Performing Investigators page

  • Study Region Overview dashboard, Non-Performing Investigators page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study Sites Initiated, only One Subject Enrolled report.

Table A-142 Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

Site Initiated

Actual

Study-Site.Site Initiated Date

Site Initiated

Days Since

Study-site Metrics.Days Since Initiation

- Study-Site Metrics

Latest Subject Enrolled Date

"- Study-site Metrics"."Latest Subject Enrolled Date"

- Study-Site Metrics

# Days Since Last Enrollment for Study-site

"- Study-site Metrics"."# Days Since Last Enrollment for Study-site"

NA

Navigate to Detail

NA

Study Team Member List (Report CDA-CO-111)

Lists all of the team members for a study.

Audience

  • Study Manager

Report Type

  • Table

Location

  • Study Overview dashboard, Study Team page

Dimensions

  • Study Team Member

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-143 describes the columns in the Study Team Member List analysis

Table A-143 Study Team Member List (Report CDA-CO-111)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study

Study

"Study"."Study"

Study Team Member

Full Name

"Study Team Member"."Full Name"

Study Team Member

Role

"Study Team Member"."Role"

Study Team Member

Start Date

"Study Team Member"."Start Date"

Study Team Member

End Date

"Study Team Member"."End Date"

Study Team Member

Email

"Study Team Member"."Email"

Study Team Member

Team Member Active

"Study Team Member"."Team Member Active"

Study-Region Information (Report CDA-CO-1113)

Displays a summary of identifying information for a study-region, including Region Name, Study #, and Study-Region Status.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • Narrative

Location

  • Study-Region Overview dashboard, Overview Study-Site Milestones page

Dimensions

  • Study, Study-Region

Supplementary Prompts

NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-144 describes the columns in the Study-Region Information analysis.

Table A-144 Study-Region Information (Report CDA-CO-1113)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

Study-Region List - Initiation Details (Report CDA-CO-306)

Lists study-regions in studies that have an approved protocol but no last subject enrolled date. Displays planned and actual number of sites, including how many are initiated, screening, and enrolling. Also displays key planned and actual milestones, as well as a milestone performance indicator. This report provides a list of ongoing study-regions that have not yet achieved 100% enrollment, including number of study-sites to reach certain achievements.

Audience

  • Study Manager Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Initiating and Recruiting Study Region page

Dimensions

  • Study, Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-145 describes the columns in the Study-Region List - Initiation Details analysis

Table A-145 Study-Region List - Initiation Details (Report CDA-CO-306)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

- Study Region Metrics

Milestone Indicator

"- Study Region Metrics"."Milestone Indicator"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study Region Metrics

# Study-Sites Planned for Study-Region

CONCAT('Planned:' , cast("- Study Region Metrics"."# Study-Sites Planned for Study-Region" as char(40)))|| '

' || CONCAT('Actual:' , cast("- Study Region Metrics"."# Study-Sites Initiated" as char(40)))

- Study Region Metrics

# Study-Sites Initiated

CONCAT('Planned:' , cast("- Study Region Metrics"."# Study-Sites Planned for Study-Region" as char(40)))|| '

' || CONCAT('Actual:' , cast("- Study Region Metrics"."# Study-Sites Initiated" as char(40)))

- Study Region Metrics

# Sites Recruiting 1 or More Subjects

CONCAT('Actual:' , cast("- Study Region Metrics"."# Sites Recruiting 1 or More Subjects" as char(40)))

- Study Region Metrics

% of Planned Sites Initiated

CONCAT('Actual:',cast(ROUND("- Study Region Metrics"."% of Planned Sites Initiated", 2) as char(40)))

- Study-Region Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study Region Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."[1st IRB/EC Submission Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Region Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]" as char(40))))||'

'||CONCAT('Actual:' , cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study-Region Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study Region Metrics

1st Site Initiated Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual :',EVALUATE('TO_CHAR(%1,%2)' as varchar(20),"- Study Region Metrics"."1st Site Initiated Date" , 'dd-Mon-yyyy'))

- Study-Region Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

[Last Site Initiated Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',MAX(cast("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('LE:',MAX(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]" as char(40))))||'

'||CONCAT('Actual Latest:' , cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

Study-Region List - KPI Performance (Report CDA-CO-1108)

Provides a list of study-regions with target/actual KPIs and a KPI indicator. This report indicates whether a study-region is performing within target range for KPIs.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-146 describes the columns in the Performance Metrics Summary Narrative: Site Visit analysis

Table A-146 Study-Region List: KPI Performance (Report CDA-CO-1108)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

NA

Study

Study

NA

Study

Study Short Title

NA

Study-Region

Study-Region Status

NA

Study-Region

Study-Region Manager

NA

Study-Region Metrics

% Sites Recruiting 0 Subjects

NA

Overall Level Targets

[Expected % Sites Recruiting 0 Subjects]

NA

Study-Region Metrics

[Median Critical Document Package Complete to Site Initiated (# Days)]

NA

Overall Level Targets

[Target Critical Document Package Complete to Site Initiated (# Days)]

NA

-

Median Site Visit Completed to Visit Report Completed

median("- Site Visit Metrics"."# Days from Site Visit Completed to Visit Report Completed")

Overall Level Targets

[Target Site Visit Completed to Visit Report Completed (# Days)]

NA

-

Median Visit Report Completed to Visit Report Approved

median("- Site Visit Metrics"."[# Days from Visit Report Completed to Visit Report Approved]"

Overall Level Targets

[Target Visit Report Completed to Visit Report Approved (# Days)]

NA

Study-Region List - Milestone Performance (Report CDA-CO-1109)

Provides a list of study-regions with planned, latest estimate and actual milestones, and a milestone indicator. This report indicates whether a study-region has exceeding planned dates for outstanding milestones.

Audience

  • Region Manager

Report Type

  • Table

Location

None

Dimensions

  • Study-Region, Study

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-147 describes the columns in the Study-Region List: Milestone Performance analysis

Table A-147 Study-Region List: Milestone Performance (Report CDA-CO-1109)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

- Study Region Metrics

Milestone Flag

"- Study Region Metrics"."Milestone Flag"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study-Region Original Planned Dates

[Planned 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study Region Metrics

[1st IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st IRB/EC Submission Date]") as char(40)))||'

'||CONCAT('Actual:',cast(MIN("- Study Region Metrics"."[1st IRB/EC Submission Date]") as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study Region Metrics

1st Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Initial IRB/EC Approval Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."1st Initial IRB/EC Approval Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study Region Metrics

1st Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual:',Cast(MIN("- Study Region Metrics"."1st Site Initiated Date") as char(40)))

- Study-Region Original Planned Dates

[Planned Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

Latest Site Initiated Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study Region Metrics

[Last Site Initiated Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Site Initiated Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Site Initiated Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Site Initiated Date" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Site Initiated Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[1st Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual:',cast("- Study Region Metrics"."[1st Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Latest Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study Region Metrics

[Last Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Critical Document Package Completed Date]") as char(40)))||'

'||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."[Latest Critical Document Package Completed Date]" as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Critical Document Package Completed Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study Region Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study Region Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study Region Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||CONCAT('Actual:',cast("- Study Region Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study Region Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study Region Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Enrolled Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study Region Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study Region Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Randomized Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study Region Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

- Study Region Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('LE:' , cast(MAX("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'

'||CONCAT('Actual(Last):',cast("- Study Region Metrics"."[Last Subject Last Visit Date]" as char(40)))||CONCAT('Actual(Latest):',cast("- Study Region Metrics"."Latest Subject Latest Visit Date" as char(40)))

Study-Region List - Recruitment Details (Report CDA-CO-433)

Lists study-regions that have initiated their first site, have not achieved 100% enrollment, and have not enrolled their last subject. Displays planned and actual recruitment information and milestones, including recruitment and milestone performance indicators. This report provides a list of ongoing study-regions that have not yet achieved 100% enrollment, including recruitment information.

Audience

  • Study Manager Region Manager

Report Type

  • Table

Location

  • Region Manager dashboard, Initiating and Recruiting Study Region page

Dimensions

  • Study, Study-Region

Supplementary Prompts

  • NA

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

Table A-148 describes the columns in the Study-Region List - Recruitment Details analysis

Table A-148 Study-Region List - Recruitment Details (Report CDA-CO-433)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Region Name

"Study-Region"."Region Name"

Study

Study

"Study"."Study"

Study

Study Short Title

"Study"."Study Short Title"

Study-Region

Study-Region Status

"Study-Region"."Study-Region Status"

Study-Region

Study-Region Manager

"Study-Region"."Study-Region Manager"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

Study-Region

Study

"Study-Region"."Study"

- Study Region Metrics

Retention Indicator

"- Study Region Metrics"."Retention Indicator"

- Study Region Metrics

Retention Detail Reason

"- Study Region Metrics"."Retention Detail Reason"

- Study Region Metrics

Milestone Indicator

"- Study Region Metrics"."Milestone Indicator"

- Study Region Metrics

Milestone Detail Reason

"- Study Region Metrics"."Milestone Detail Reason"

- Study-Region Targets

[Expected Screen Failure Rate]

CONCAT('Expected:' , MIN(cast(ROUND("- Study-Region Targets"."[Expected Screen Failure Rate]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Region Metrics"."Screen Failure Rate", 2) as char(40)))

- Study Region Metrics

Screen Failure Rate

CONCAT('Expected:' , MIN(cast(ROUND("- Study-Region Targets"."[Expected Screen Failure Rate]", 2) as char(40))))||'

'||CONCAT('Actual:' , cast(ROUND("- Study Region Metrics"."Screen Failure Rate", 2) as char(40)))

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

- Study-Region Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Region Original Planned Dates"."[Planned 1st Subject Screened Date]") as char(40)))||'

'||CONCAT('LE:',cast(MIN("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Region Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned 1st Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual:' , cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Site Metrics

[Last Subject Enrolled Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Enrolled Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Enrolled Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Enrolled Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Randomized Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Randomized Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject 1st Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Region Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Region Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',MIN(cast("- Study-Region Original Planned Dates"."[Planned Last Subject Last Visit Date]" as char(40))))||'

'||CONCAT('LE:',MIN(cast("- Study-Region Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]" as char(40))))||'

'|| CONCAT('Actual Latest:' , cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'

'||CONCAT('Actual Last:' , cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Region Metrics

1st Site Initiated Date

"- Study Region Metrics"."1st Site Initiated Date"

- Study Metrics

% Planned Subjects Enrolled (Study)

"- Study Metrics"."% Planned Subjects Enrolled (Study)"

- Study Metrics

[Last Subject Enrolled Date]

"- Study Metrics"."[Last Subject Enrolled Date]"

Study-Region List and Recruitment Counts (Report CDA-CO-404)

Lists all study regions and recruitment counts. This report indicates how well each region is progressing toward recruitment goals.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Recruitment Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Region List and Recruitment Counts report.

Table A-149 Study-Region List and Recruitment Counts (Report CDA-CO-404)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study Region

Name

Study-Site.Study Region

Study Region

Status

Study-Site.Study Region Status

# Subjects

Planned for Region

Region Metrics.# Subjects Planned for Region

# Subjects

Planned for Study-Site

Study-site Metrics.# Subjects Planned for Study-Site

# Subjects

Screened

Study-site Metrics.# Screened

# Subjects

Screen Failure

Study-site Metrics.# Screen Failure

# Subjects

Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

# Subjects

Randomized

Study-site Metrics.# Randomized

% to Plan

Site Enrollment

Study-site Metrics.% of Planned Site Enrollment Completed

Study-Region Team Member List (Report CDA-CO-1107)

Lists all of the team members for a study-region.

Audience

  • Region Manager

Report Type

  • Table

Location

  • Study-Region Overview dashboard, Study-Region Team page

Dimensions

  • Study-Region Team Member

Supplementary Prompts

  • NA

Reports Referenced

None

Column Descriptions

Table A-150 describes the columns in the Study-Region Team Member List analysis.

Table A-150 Study-Region Team Member List (Report CDA-CO-1107)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region Team Member

Full Name

"Study-Region Team Member"."Full Name"

Study-Region Team Member

Role

"Study-Region Team Member"."Role"

Study-Region Team Member

Start Date

"Study-Region Team Member"."Start Date"

Study-Region Team Member

End Date

"Study-Region Team Member"."End Date"

Study-Region Team Member

Email

"Study-Region Team Member"."Email"

Study-Region Team Member

Team Member Active

"Study-Region Team Member"."Team Member Active"

Study-Site Enrollment Progress Gauge (Report CDA-CO-455)

Displays a gauge showing how many subjects have been enrolled in the study-site compared to the number of subjects planned for the study-site.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study-Site Information (Report CDA-CO-206)

Displays a summary of identifying information for a study-site, including Study #, Program, Study-Site ID, Principal Investigator and Study-Site Status.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Information report.

Table A-151 Study-Site Information (Report CDA-CO-206)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Program

Study-Site.Program

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

CRA

Study-Site.CRA

NA

Status

Study-Site.Study-Site Status

NA

Study Region

Study-Site.Study Region

Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Lists study-sites grouped by those with no subjects enrolled and those with 1 or more subjects enrolled. This report indicates which study-sites are performing better than others.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Overview dashboard, Site Performance page

  • Study-Region Overview dashboard, Site Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site List by Recruitment Performance Group report.

Table A-152 Study-Site List by Recruitment Performance Group (Report CDA-CO-401)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

Study-Site

Study

"Study-Site"."Study"

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

CRA

Study-Site.CRA

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

- Study-site Metrics.% of Planned Site Enrollment Completed

NA

# Days Since Last Enrollment for Study-site

- Study-site Metrics.# Days Since Last Enrollment for Study-site

NA

Navigate to Detail

NA

Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

Lists study-sites including key CRF and discrepancy (query) metrics as well as progress tracking for data management. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Data Management View report.

Table A-153 Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

Lists study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List - Monitoring View with Indicators report.

Table A-154 Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Recruitment Detail View report.

Table A-155 Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention, milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Retention Detail View report.

Table A-156 Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Site Start Up Detail View report.

Table A-157 Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Study Close Detail View report.

Table A-158 Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study Region Overview dashboard, Study-Site Milestones page

  • CRA, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site List with Indicators - Summary View report.

Table A-159 Study-Site List with Indicators - Summary View (Report CDA-CO-207G)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Study-Site

CRA

Study-Site.CRA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

Lists study-sites including key monitoring metrics as well as progress tracking for site monitoring. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Monitoring View report.

Table A-160 Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To BeApproved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Recruitment Detail View report.

Table A-161 Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Retention Detail View report.

Table A-162 Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View report.

Table A-163 Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicators for milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Study Close Detail View report.

Table A-164 Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft Locked

"- Received CRFs"."# CRFs Soft Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard Locked

"- Received CRFs"."# CRFs Hard Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Summary View report.

Table A-165 Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date" ) as char(40)))

Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Lists study-sites including key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment and retention. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates which study-sites require action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Study-Site Milestones page

  • Study Region Overview dashboard, Study-Site Milestones page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (CRA) - Data Management View report.

Table A-166 Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

NA

Navigate to Detail

NA

- Discrepancies (Queries

# Open Discrepancies (Queries

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries

# Total Discrepancies (Queries

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries

# Days Discrepancy (Query) Open

("- Discrepancies"."# Days Discrepancy Open"/ "-Discrepancies"."# TotalDiscrepancies")

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To beVerified"

- Received CRFs

# CRFs Soft Locked (Frozen)

"- Received CRFs"."# CRFs Soft Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard Locked (Locked)

"- Received CRFs"."# CRFs Hard Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

Lists (for a study-site) key milestone dates and enrollment, enrollment progress, and study-site-health indicator. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Data Management View report.

Table A-167 Study-Site Milestones with Indicators (Single Study-Site) - Data Management View (Report CDA-CO-203A)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Days Discrepancy (Query) Open

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Discrepancies (Queries)

# Total Discrepancies (Queries)

"- Discrepancies"."# Days Discrepancy Open"/"- Discrepancies"."# Total Discrepancies"

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked (Frozen)

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked (Frozen) / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked (Locked)

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked (Locked) / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

Lists (for a study-site) key monitoring dates as well as progress tracking for site monitoring. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View report.

Table A-168 Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Metrics

Latest Site Visit Completed Date

"- Study-Site Metrics"."Latest Site Visit Completed Date"

- Study-Site Metrics

Latest Site Visit Type

"- Study-Site Metrics"."Latest Site Visit Type"

- Study-Site Metrics

# Days Since Latest Site Visit

TRUNCATE("- Study-Site Metrics"."# Days Since Latest Site Visit",0)

- Study-Site Metrics

Median # Days Between Site Visits

"- Study-Site Metrics"."Median # Days Between Site Visits"

- Study-Site Metrics

# Subjects Enrolled Since Latest Site Visit

"- Study-Site Metrics"."# Subjects Enrolled Since Latest Site Visit"

- Discrepancies (Queries)

# Open Discrepancies (Queries)

"- Discrepancies"."# Open Discrepancies"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Study-Site Metrics

# Visit Reports Awaiting Completion

"- Study-Site Metrics"."# Visit Reports Awaiting Completion"

- Study-Site Metrics

[# Visit Reports Awaiting Approval]

"- Study-Site Metrics"."[# Visit Reports Awaiting Approval]"

- Site Visit Metrics

# Outstanding Follow Up Items

"- Site Visit Metrics"."# Outstanding Follow Up Items"

Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site recruitment. Includes study-site-health indicators for recruitment and milestones. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View report.

Table A-169 Study-Site Milestones with Indicators (Single Study-Site) - Recruitment Detail View (Report CDA-CO-203C)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Metrics

% Randomized vs. Planned - Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Randomized vs. Planned - Study-Site",2) as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject 1st Visit Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Metrics

1st Subject 1st Visit Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject 1st Visit Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Screened Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Metrics

1st Subject Screened Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Screened Date]" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Screened Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Screened Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject 1st Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject 1st Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject 1st Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject 1st Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject 1st Visit Date]" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site retention. Includes study-site-health indicators for retention and milestones. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View report.

Table A-170 Study-Site Milestones with Indicators (Single Study-Site) - Retention Detail View (Report CDA-CO-203D)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE 1st Subject Randomized Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Metrics

1st Subject Randomized Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE 1st Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Randomized Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up. Includes study-site-health indicator for milestones. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View report.

Table A-171 Study-Site Milestones with Indicators (Single Study-Site) - Site Start Up Detail View (Report CDA-CO-203E)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Document Metrics

# Documents Outstanding

"- Document Metrics"."# Documents Outstanding"

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MIN("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date"as char(40)))

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for study close. Includes study-site-health indicator for milestones. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View report.

Table A-172 Study-Site Milestones with Indicators (Single Study-Site) - Study Close Detail View (Report CDA-CO-203F)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

Latest Subject Randomized Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Metrics

[Last Subject Randomized Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Randomized Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Randomized Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Randomized Date]"as char(40)))

- Study-Site Original Planned Dates

[Planned Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

Latest Subject Latest Visit Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Study-Site Metrics

[Last Subject Last Visit Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Last Subject Last Visit Date]") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Latest Visit Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."[Last Subject Last Visit Date]" as char(40)))

- Received CRFs

# CRFs Awaiting Entry Completion

"- Received CRFs"."# CRFs Awaiting Entry Completion"

- Received CRFs

# eCRFs To Be Approved

"- Received CRFs"."# eCRFs To Be Approved"

- Received CRFs

# eCRFs To be Verified

"- Received CRFs"."# eCRFs To be Verified"

- Received CRFs

# CRFs Soft- Locked

"- Received CRFs"."# CRFs Soft- Locked"

- Received CRFs

% CRFs Soft Locked / Entry Complete

"- Received CRFs"."% CRFs Soft Locked / Entry Complete"

- Received CRFs

# CRFs Hard-Locked

"- Received CRFs"."# CRFs Hard-Locked"

- Received CRFs

% CRFs Hard Locked / Entry Complete

"- Received CRFs"."% CRFs Hard Locked / Entry Complete"

- Study Original Planned Dates

[Planned Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Latest Estimated Dates

[Planned LE Database Lock Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Key Dates

Database Lock Date

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Database Lock Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Database Lock Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."Database Lock Date") as char(40)))

- Study Original Planned Dates

[Planned Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Latest Estimated Dates

[Planned LE Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

- Study Key Dates

[Clinical Study Report Date]

CONCAT('Planned:',cast(MAX("- Study Original Planned Dates"."[Planned Clinical Study Report Date]")as char(40))) || '<br/>' ||CONCAT('LE:',cast(MAX("- Study Latest Estimated Dates"."[Planned LE Clinical Study Report Date]") as char(40))) || '<br/>' ||CONCAT('Actual:',cast(MAX("- Study Key Dates"."[Clinical Study Report Date]") as char(40)))

Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

Lists (for a study-site) key planned, latest estimate and actual milestone dates as well as progress tracking for site start up, recruitment, retention, and study close. Includes study-site-health indicators for recruitment, retention and milestones. This report indicates whether a study-site requires action, and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Milestones with Indicators (Single Study-Site) - Summary View report.

Table A-173 Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)

Table Heading Column Heading Measure/Dimension in Presentation Layer

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment High Level Reason

"- Study-Site Metrics"."Recruitment High Level Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention High Level Reason

"- Study-Site Metrics"."Retention High Level Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone High Level Reason

"- Study-Site Metrics"."Milestone High Level Reason"

- Study Targets

[Expected Screen Failure Rate]

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

Screen Failure Rate

CONCAT('Expected:',cast(MAX("- Study Targets"."[Expected Screen Failure Rate]") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."Screen Failure Rate",2) as char(40)))

- Study-Site Metrics

% Enrolled to Total Planned at Study-Site

CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Enrolled to Total Planned at Study-Site",2) as char(40)))

- Study-Site Study-Site Targets

Expected Early Termination Rate

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

% Subjects Early Terminated for Study-Site

CONCAT('Expected:',cast(MAX("- Study-Site Study-Site Targets"."Expected Early Termination Rate") as char(40)))||'<br/>'||CONCAT('Actual:' , cast(ROUND("- Study-Site Metrics"."% Subjects Early Terminated for Study-Site",2)as char(40)))

- Study-Site Metrics

Next Site Visit Date

"- Study-Site Metrics"."Next Site Visit Date"

- Study-Site Metrics

Next Site Visit Type

"- Study-Site Metrics"."Next Site Visit Type"

- Study-Site Original Planned Dates

Planned 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE 1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Metrics

1st Subject Enrolled Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."Planned 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE 1st Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Metrics"."1st Subject Enrolled Date" as char(40)))

- Study-Site Original Planned Dates

Planned Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Latest Estimated Dates

Planned LE Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Latest Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

Last Subject Enrolled Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."Planned Last Subject Enrolled Date" )as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."Planned LE Last Subject Enrolled Date") as char(40)))||'<br/>'||CONCAT('Actual(Latest):',cast("- Study-Site Metrics"."Latest Subject Enrolled Date" as char(40)))||'<br/>'||CONCAT('Actual(Last):',cast("- Study-Site Metrics"."Last Subject Enrolled Date" as char(40)))

- Study-Site Metrics

# Days Since Last Enrollment for Study-Site

TRUNCATE("- Study-Site Metrics"."# Days Since Last Enrollment for Study-Site",0)

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

Study-Site Missed Dose Details (Report CDA-CO-215)

Lists the number of times a Study-Site has missed dosing subjects, usually due to lack of supply. Includes the date the dose was missed, the date entered, and any comments about the missed dose.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Not included on a dashboard

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

Study-Site Missed Dose Tile (Report CDA-CO-220)

Lists the number of times a Study-Site has missed dosing subjects, usually due to lack of supply. Includes the date the dose was missed, the date entered and any comments about the missed dose.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Study-Site RACT (Report CDA-CO-856)

Displays the RACT (Risk Assessment Categorization Tool) for a Study-Site. This analysis lists all the questions on the RACT with the scores for impact, probability, and detectability. it also lists any considerations, mitigations, or comments.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Not located on a dashboard

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

Study-Site RACT by Category (Report CDA-CO-857)

Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study-Site.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Not included on a dashboard

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

Study-Site RACT Score Tile (Report CDA-CO-859)

Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study-Site.

Audience

  • Study Manager

  • CRA

Report Type

  • Tile

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Study-Site Risk Indicator Map (Report CDA-CO-1210)

Map of multiple risk indicators for the study-sites in the study.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Map with Table

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

Displays a summary of recruitment information for a study-site. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Subject Recruitment Narrative report.

Table A-174 Study-Site Subject Recruitment Narrative (Report CDA-CO-405)

Table Heading Column Heading Measure/Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

For Study-Site:

# Screened

Study-site Metrics.# Screened

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

% of Planned Site Enrollment Completed

Study-site Metrics.% of Planned Site Enrollment Completed

NA

% of Total Enrolled in Study

Study-site Metrics.% of Total Enrolled in Study

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Randomized vs. Planned - Study

Study Metrics.% Randomized vs. Planned - Study

NA

% of Total Randomized in Study

Study-site Metrics.% of Total Randomized in Study

Study-Site Subject Retention (Report CDA-CO-500)

Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Study-Site Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Site Subject Retention report.

Table A-175 Study-Site Subject Retention (Report CDA-CO-500)

Table Heading Column Heading Measure/Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study:

% Early Terminated

Study-site Metrics.% Subjects Early Terminated for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

For Study-Site:

# Enrolled (to date)

Study-Site Metrics.# Enrolled

For Study-Site:

# Subjects - Current Status Enrolled

Study-site Metrics.# Subjects - Current Status Enrolled

NA

# Completed

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

% Early Terminated

Study-site Metrics.% Subjects Early Terminated for Study-site

Study-Site Team Member List (Report CDA-CO-201)

Lists all of the team members for a study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • Study-Site Overview dashboard, Study-Site Team page

Dimensions

  • Study-Site Team Member

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

The table describes the columns in the Study-Site Team Member List report.

Table A-176 Study-Site Team Member List (Report CDA-CO-201)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Last Name

Study-Site Team Member.Last Name

NA

First Name

Study-Site Team Member.First Name

NA

Role

Study-Site Team Member.Role

NA

Start Date

Study-Site Team Member.Start Date

NA

End Date

Study-Site Team Member.End Date

NA

Email

Study-Site Team Member.Email

NA

Team Member Active

Study-Site Team Member.Team Member Active

NA

Team Member Comment

Study-Site Team Member.Team Member Comment

Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Lists study-sites with an indicator of study-site health, where the indicator is red or yellow. This report indicates which study-sites require action and why.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, CRA Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following report from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Study-Sites with Red or Yellow Performance Flag report.

Table A-177 Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Site

Program

Study-Site.Program

Study-Site

Study

Study-Site.Study

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Status

Study-Site.Study-Site Status

NA

Navigate to detail

NA

- Study-Site Metrics

Recruitment Flag

"- Study-Site Metrics"."Recruitment Flag"

- Study-Site Metrics

Recruitment Detail Reason

"- Study-Site Metrics"."Recruitment Detail Reason"

- Study-Site Metrics

Retention Flag

"- Study-Site Metrics"."Retention Flag"

- Study-Site Metrics

Retention Detail Reason

"- Study-Site Metrics"."Retention Detail Reason"

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

Subject Enrollment by Region (Report CDA-CO-414)

Shows the distribution of subject enrollment by region. This report indicates which regions are contributing the most to recruitment.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Study Region Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Enrollment by Region report.

Table A-178 Subject Enrollment by Region (Report CDA-CO-414)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)

Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study Overview dashboard, Risk Profile page

Dimensions

  • Study

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)

Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study-site level.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Gauge

Location

  • Study-Site Overview dashboard, Risk Profile page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Subject Recruitment (Report CDA-CO-419)

Displays a summary of recruitment information for a study. This report indicates planned recruitment versus actual screening, enrollment and randomization information for a single study.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Recruitment report.

Table A-179 Subject Recruitment (Report CDA-CO-419)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Screened

Study-site Metrics.# Screened

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Randomized

Study-site Metrics.# Randomized

NA

% Enrolled / Planned

Study Metrics.% Enrolled / Planned in Study

NA

% Randomized / Planned

Study Metrics.% Randomized vs. Planned Study

Subject Recruitment (Study Region) (Report CDA-CO-1114)

Displays a summary of recruitment information for a study-region. This report indicates planned recruitment vs. actual screening, enrollment and randomization information for a single study-region.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • Narrative

Location

  • Study-Region Overview dashboard, Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-180 describes the columns in the Subject Recruitment (Study Region) analysis

Table A-180 Subject Recruitment (Study Region) (Report CDA-CO-1114)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Metrics

# Subjects Planned for Study

"- Study Metrics"."# Subjects Planned for Study"

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Screened

"- Study-site Metrics"."# Screened"

- Study-Site Metrics

# Enrolled

"- Study-site Metrics"."# Enrolled"

- Study Region Metrics

% Enrolled to Total Planned at Study Region

"- Study Region Metrics"."% Enrolled to Total Planned at Study Region"

- Study-Site Metrics

% of Total Enrolled in Study

"- Study-site Metrics"."% of Total Enrolled in Study"

- Study-Site Metrics

# Randomized

"- Study-site Metrics"."# Randomized"

- Study Region Metrics

% Planned Subjects Randomized

"- Study Region Metrics"."% Planned Subjects Randomized"

- Study-Site Metrics

% of Total Randomized in Study

"- Study-site Metrics"."% of Total Randomized in Study"

Study-Region

Study

"Study-Region"."Study"

Subject Retention (Report CDA-CO-504)

Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study Overview dashboard, Study Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention report.

Table A-181 Subject Retention (Report CDA-CO-504)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

# Planned for Study

Study Metrics.# Subjects Planned for Study

NA

# Current Active

Study-site Metrics.# Current Active Subjects

NA

# Completed Study

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

% Early Term / Planned

CAST(- Study-site Metrics.# Early Terminations*100 /- Study Metrics.# Subjects Planned for Study AS FLOAT)

Subject Retention (Study Level) (Report CDA-CO-503)

Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study Overview dashboard, Retention Overview page

Dimensions

None

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention (Study Level) report.

Table A-182 Subject Retention (Study Level) (Report CDA-CO-503)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

# Planned

Study Metrics.# Subjects Planned for Study

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Completed Study

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminations

Study-site Metrics.# Early Terminations

NA

# Early Term / Planned

Study-site Metrics.# Early Terminations/- Study Metrics.# Subjects Planned for Study

Subject Retention (Study Region) (Report CDA-CO-1115)

Displays a summary of retention information for a study-region. This report indicates planned recruitment vs. actual retention information for a single study-region.

Audience

  • Region Manager

  • Study Manager

  • Executive Manager

  • Program Manager

Report Type

  • Narrative

Location

  • Study-Region Overview dashboard, Overview Retention Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • NA

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-183 describes the columns in the Subject Retention (Study Region) analysis.

Table A-183 Subject Retention (Study Region) (Report CDA-CO-1115)

Table Heading Column Heading Measure or Dimension in Presentation Layer

Study-Region

Study

"Study-Region"."Study"

- Study Metrics

# Subjects Planned for Study

"- Study Metrics"."# Subjects Planned for Study"

- Study Metrics

% Subjects Early Terminated for Study

"- Study Metrics"."% Subjects Early Terminated for Study"

Study-Region

Study-Region Name

"Study-Region"."Study-Region Name"

- Study Region Metrics

# Subjects Planned for Study-Region

"- Study Region Metrics"."# Subjects Planned for Study-Region"

- Study-Site Metrics

# Enrolled

"- Study-Site Metrics"."# Enrolled"

- Study-Site Metrics

# Subjects - Current Status Enrolled

"- Study-Site Metrics"."# Subjects - Current Status Enrolled"

- Study-Site Metrics

# Subjects - Current Status Completed

"- Study-Site Metrics"."# Subjects - Current Status Completed"

- Study-Site Metrics

# Early Terminations

"- Study-Site Metrics"."# Early Terminations"

- Study Region Metrics

% Subjects Early Terminated for Study-Region

"- Study Region Metrics"."% Subjects Early Terminated for Study-Region"

Subject Retention (Study-Site Level) (Report CDA-CO-502)

Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Narrative

Location

  • Study-Site Overview dashboard, Retention Overview page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention (Study-Site Level) report.

Table A-184 Subject Retention (Study-Site Level) (Report CDA-CO-502)

Table Heading Column Heading Measure or Dimension in Presentation Layer

For Study:

# Planned

Study Metrics.# Subjects Planned for Study

For Study-Site:

# Planned

Study-site Metrics.# Subjects Planned for Study-Site

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Completed

Study-site Metrics.# Subjects who have completed Study

NA

# Early Terminated

Study-site Metrics.# Early Terminations

NA

% Early Terminated

Study-site Metrics.# Early Terminations/- Study Metrics.# Subjects Planned for Study

Subject Retention Over Time (Study Level) (Report CDA-CO-501)

Shows cumulative subjects completed and early terminated over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject retention and early termination.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Retention Overview page

Dimensions

  • Study-Site

  • All-Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subject Retention Over Time (Study Level) report.

Table A-185 Subject Retention Over Time (Study Level) (Report CDA-CO-501)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Completed

RSUM(- Study-site Metrics.# Subjects who have completed Study)

Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

Displays cumulative subjects off study over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study-site. This report indicates the progress of subject retention.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Retention Overview page

Dimensions

  • Study-Site All-Purpose Date

Supplementary Prompts

None

Reports Referenced

None

Column Descriptions

The table describes the columns in the Subject Retention Over Time (Study-Site Level) report

Table A-186 Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

1

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END))

NA

0.9

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .9)

NA

0.75

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .75)

NA

0.5

MAX(SUM(CASE WHEN - Study Metrics.# Subjects Planned for Study>0 THEN - Study Metrics.# Subjects Planned for Study ELSE 0 END) * .5)

NA

# Subjects Completed

RSUM(- Study-site Metrics.# Subjects who have completed Study)

Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

Shows cumulative subjects completed and early terminated over time, compared to static planned subjects enrolled (50%, 75%, 90% and 100%) for a study. This report indicates the progress of subject retention and early termination.

Audience

  • Region Manager

  • Study Manager

  • CRA

Report Type

  • View Selector (2 Charts, Table)

Location

  • Study-Region Overview dashboard, Overview Retention Overview page

Dimensions

  • Study-Region

Supplementary Prompts

  • Year and Month Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

Table A-187 describes the columns in the Subject Retention Over Time Chart (Study-Region Level) analysis

Table A-187 Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)

Table Heading Column Heading Measure or Dimension in Presentation Layer

- All Purpose Date

Year and Month

"- All Purpose Date"."Year and Month"

Study-Region

Study

"Study-Region"."Study"

Study-Region

Region Name

"Study-Region"."Region Name"

- Study-Site Metrics

# Subjects who have completed Study

IFNULL(RSUM("- Study-Site Metrics"."# Subjects who have completed Study"), 0) + @{pv_subjects_completed_stdy_reg}

- Study-Site Metrics

# Early Terminations

IFNULL(RSUM("- Study-Site Metrics"."# Early Terminations"), 0) + @{pv_early_term_stdy_region}

Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

Displays the number of subjects enrolled per month. This report indicates the pattern of enrollment over time at a study-site.

Audience

  • Study Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study-Site Overview dashboard, Monitoring Metrics page

Dimensions

  • Study-Site

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Subjects Enrolled per Month, Over Time report

Table A-188 Subjects Enrolled per Month, Over Time (Report CDA-CO-403)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

Year and Month

All Purpose Date.Year and Month

Subjects who Failed Screening (Report CDA-CO-428)

Lists (by program, study, and site) all subjects who have failed screening, including screen failure reason and subject comments. This report indicates which screen failure reasons account for the most screen failures.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

None

Dimensions

  • Study-Site

  • Subject

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

The table describes the columns in the Subjects who Failed Screening report.

Table A-189 Subjects who Failed Screening (Report CDA-CO-428)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Subject

Screening #

Subject.Screening #

Subject

Screen Failure Reason

Subject.Screen Failure Reason

Subject

Subject Comments

Subject.Subject Comments

NA

Subject Status

Subject Metrics.Subject Status

NA

Status Comment

Subject Metrics.Status Comment

Subjects Withdrawn List (Report CDA-CO-509)

Lists (by program, study, region, and site) all subjects who terminated the study early, including withdrawn reason and subject comments. This report indicates which withdrawn reasons account for the most early terminations.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

None

Dimensions

  • Study-Site

  • Subject

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

You can navigate to this report from the following reports:

Column Descriptions

The table describes the columns in the Subjects Withdrawn List report.

Table A-190 Subjects Withdrawn List (Report CDA-CO-509)

Table Heading Column Heading Measure/Dimension in Presentation Layer

Product

Product Name

Study-Site.Product

Region

Region Status

Study-Site.Study Region Status

Study

Study Status

Study-Site.Study Status

Study-Site

Principal Investigator

Study-Site.Principal Investigator

Study-Site

Program

Study-Site.Program

Study-Site

Site Name

Study-Site.Site Name

Study-Site

Study

Study-Site.Study

Study-Site

Study Region

Study-Site.Study Region

Study-Site

Study-Site ID #

Study-Site.Study-Site ID #

Study-Site

Study-Site Status

Study-Site.Study-Site Status

Subject

Enrollment Id

Subject.Enrollment Id

Subject

Withdrawn Reason

Subject.Withdrawn Reason

Subject

Subject Comments

Subject.Subject Comments

NA

Subject Status

Subject Metrics.Subject Status

NA

Status Comment

Subject Metrics.Status Comment

Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Identifies specific subjects who have eCRFs awaiting processing. This report indicates those subjects which require processing, and the number of eCRFs to be processed. This information can be used as a summary work log to take to a site visit to drive activity.

Audience

  • Data Manager

Report Type

  • Table

Location

  • Data Manager - EDC dashboard, Study Processing Summary page

Dimensions

  • Study-Site

  • Subject

Supplementary Prompts

  • Study

  • Study-Site

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

The following reports reference this report:

Column Descriptions

The table describes the columns in the Summary of Subjects Awaiting EDC Processing report.

Table A-191 Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

# eCRFs

Entry Complete

Received CRFs.# eCRFs Entry Complete

# eCRFs

Not Verified

Received CRFs.# eCRFs Never Verified

# eCRFs

Awaiting Re-Verification

Received CRFs.# eCRFs Awaiting Re-Verification

# eCRFs

Not Approved

Received CRFs.# eCRFs Not Approved

# eCRFs

Awaiting Re-Approval

Received CRFs.# eCRFs Awaiting Re-Approval

Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Identifies specific CRFs, and the process steps they are awaiting. This report lists, for a subject, the pages which are awaiting processing. This information can be used to drive activity.

Audience

  • Data Entry Manager

  • Data Manager

Report Type

  • Table

Location

  • Data Manager - Paper dashboard, Study Processing Summary page

Dimensions

  • Study-Site

  • Subject

Supplementary Prompts

  • Study

  • Study-Site

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

The following reports reference this report:

  • Key Paper processing volumes (Report CDA-DM-405)

Column Descriptions

The table describes the columns in the Summary of Subjects Awaiting Paper Processing report

Table A-192 Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

NA

Study-Site.Program

NA

NA

Study-Site.Study Name

Subject

Subject ID

Subject.Subject ID

# CRFs

Present

Received CRFs.# pCRFs Present

# CRFs

Awaiting First Entry Completion

Received CRFs.# pCRFs Awaiting Pass 1 Entry Completion

# CRFs

Awaiting Second Entry Completion

Received CRFs.# pCRFs Awaiting Pass 2 Entry Completion

Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Lists the top investigators based on % planned enrollment completed for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

  • Executive

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Manager dashboard, Top Investigators page

  • CRA dashboard, Top Investigators page

  • Study Overview dashboard, Top Investigators page

  • Executive dashboard, Top Investigators page

  • Region Manager dashboard, Top Investigators page

  • Study-Region Overview dashboard, Top Investigators page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators Compared to All Investigators for Study, Total Enrollment report.

Table A-193 Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Study-Site ID #

TBD

NA

Principal Investigator

TBD

NA

# Subjects Enrolled

Study-site Metrics.# Subjects Enrolled

NA

Rank

TBD

Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

Lists the top investigators based on % planned enrollment completed for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

  • Executive

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Top Investigators page

  • CRA dashboard, Top Investigators page

  • Study Overview dashboard, Top Investigators page

  • Executive dashboard, Top Investigators page

  • Region Manager dashboard, Top Investigators page

  • Study-Region Overview dashboard, Top Investigators page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators, % Planned Enrollment Completed report.

Table A-194 Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

% Enrolled to Total Planned at Study-Site

Study-site Metrics.% Enrolled to Total Planned at Study-Site

NA

Rank

rank (- Study-site Metrics.% Enrolled to Total Planned at Study-Site)

Top Investigators, Total Enrollment (Report CDA-CO-701)

Lists the top investigators based on total number of subjects enrolled for study-sites that are either completely enrolled or study-sites that are closed. This report indicates who the top performing investigators in the study are.

Audience

  • Executive

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Table

Location

  • Study Manager dashboard, Top Investigators page

  • CRA dashboard, Top Investigators page

  • Study Overview dashboard, Top Investigators page

  • Executive dashboard, Top Investigators page

  • Region Manager dashboard, Top Investigators page

  • Study-Region Overview dashboard, Top Investigators page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Top Investigators, Total Enrollment report.

Table A-195 Top Investigators, Total Enrollment (Report CDA-CO-701)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Study

Study-Site.Study

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

# Enrolled

- Study-site Metrics.# Subjects Enrolled

NA

Rank

Rank (- Study-site Metrics.# Subjects Enrolled)

Total Subject Enrollment by Region (Report CDA-CO-410)

Shows cumulative actual enrollment by region. This report indicates which regions are contributing the most to recruitment.

Audience

  • Study Manager CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Study Region Performance page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Total Subject Enrollment by Region report.

Table A-196 Total Subject Enrollment by Region (Report CDA-CO-410)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study Region

Study-Site.Study Region

NA

Site Name

OCDA.Study-Site.Site Name

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

Uninitiated Sites (Report CDA-CO-304)

Lists study-sites that have not yet been initiated, including whether they've received IRB/EC approval and number of outstanding documents. This report indicates which study-sites are awaiting initiation and possible reasons for delay.

Audience

  • Study Manager

  • CRA

Report Type

  • Table

Location

  • CRA dashboard, Initiating and Recruiting Study-Sites page

Dimensions

  • Study-Site

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Uninitiated Sites report.

Table A-197 Uninitiated Sites (Report CDA-CO-304)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Study

Study-Site.Study

Study-Site

Study Region

"Study-Site"."Study Region"

NA

Study-Site ID #

Study-Site.Study-Site ID #

NA

Principal Investigator

Study-Site.Principal Investigator

NA

Site Name

Study-Site.Site Name

NA

Study-Site Status

Study-Site.Study-Site Status

NA

Initial IRB/EC Approval Date

Study-Site.Initial IRB/EC Approval Date

- Study-Site Original Planned Dates

[Planned IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Key Dates

[Initial IRB/EC Submission Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE IRB/EC Submission Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Initial IRB/EC Submission Date]") as char(40)))

- Study-Site Metrics

Milestone Flag

"- Study-Site Metrics"."Milestone Flag"

- Study-Site Metrics

Milestone Detail Reason

"- Study-Site Metrics"."Milestone Detail Reason"

- Study-Site Original Planned Dates

[Planned Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Initial IRB/EC Approval Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Key Dates

Initial IRB/EC Approval Date

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Initial IRB/EC Approval Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast("- Study-Site Key Dates"."Initial IRB/EC Approval Date" as char(40)))

- Study-Site Original Planned Dates

[Planned Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Site Initiated Date]

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

- Study-Site Key Dates

Site Initiated Date

CONCAT('Planned:',cast(MAX("- Study-Site Original Planned Dates"."[Planned Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Site Initiated Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."Site Initiated Date") as char(40)))

Study-Site

Site Name

"Study-Site"."Site Name"

- Study-Site Original Planned Dates

[Planned Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Latest Estimated Dates

[Planned LE Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

- Study-Site Key Dates

[Critical Document Package Completed Date]

CONCAT('Planned:',cast(MIN("- Study-Site Original Planned Dates"."[Planned Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('LE:' , cast(MAX("- Study-Site Latest Estimated Dates"."[Planned LE Critical Document Package Completed Date]") as char(40)))||'<br/>'||CONCAT('Actual:',cast(MAX("- Study-Site Key Dates"."[Critical Document Package Completed Date]") as char(40)))

NA

# Documents Outstanding

Document Metrics.# Documents Outstanding

NA

Navigate to Detail

NA

Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

Shows the number of site visits and number of subjects enrolled over time. This report indicates the relationship between subject enrollment and the number of site visits.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, Table (optional)

Location

  • Study Overview dashboard, Monitoring Metrics page

  • Study Overview dashboard, Monitoring Metrics page

  • Region Manager dashboard, Monitoring Metrics page

Dimensions

  • All Purpose Date

Supplementary Prompts

Year Prompt

Reports Referenced

None

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Visit Frequency Compared to Subject Enrollment report.

Table A-198 Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)

Table Heading Column Heading Measure or Dimension in Presentation Layer

NA

Year and Month

All Purpose Date.Year and Month

NA

# Enrolled

Study-site Metrics.# Subjects Enrolled

NA

# Site Visits

Study-site Metrics.# Site Visits

Withdrawn Reason (Report CDA-CO-505)

Displays (by withdrawn reason) the number of subjects who terminated early. This report indicates which withdrawn reasons account for the most early terminations.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Retention Overview page

  • Study-Site Overview dashboard, Retention Overview page

  • Study-Region Overview dashboard, Retention Overview page

Dimensions

  • Subject

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Withdrawn Reason report.

Table A-199 Withdrawn Reason (Report CDA-CO-505)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

Count of Early Terms

COUNT(CASE WHEN - Subject Metrics.Subject Status='EARLY TERM' OR - Subject Metrics.Subject Status='Early Terminated' THEN - Subject Metrics.Subject Status END)

NA

Withdrawn Reason

Subject.Withdrawn Reason

Withdrawn Reason Overview (Report CDA-CO-508)

Displays (by site) the number of early terminations. This report indicates which withdrawn reasons account for the most early terminations.

Audience

  • Study Manager

  • Region Manager

  • CRA

Report Type

  • Graph, table (optional)

Location

  • Study Overview dashboard, Retention Overview page

  • Study-Region Overview dashboard, Retention Overview page

Dimensions

  • Subject.Withdrawn Reason

  • Study-Site.Study, Site, and Investigator

Supplementary Prompts

None

Reports Referenced

You can navigate to the following reports from this report:

Reports Referencing This Report

None

Column Descriptions

The table describes the columns in the Withdrawn Reason Overview report.

Table A-200 Withdrawn Reason Overview (Report CDA-CO-508)

Table Heading Column Heading Measure/Dimension in Presentation Layer

NA

# Early Terminations

Study-site Metrics.# Early Terminations

Subject

Withdrawn Reason

Subject.Withdrawn Reason

Study-Site

Study, Site, and Investigator

Study-Site.Study, Site, and Investigator

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