Oracle® Health Sciences Clinical Development Analytics User's Guide Release 3.2 E74647-01 |
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This section describes predefined dashboards and analyses delivered with Oracle Health Sciences Clinical Development Analytics (OHSCDA):
Oracle Health Sciences Clinical Development Analytics Dashboards
Oracle Health Sciences Clinical Development Analytics Analyses
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).Log on to OHSCDA as a user with the administrator role.
Click Catalog.
Under Folders on the left pane, navigate to Shared Folders > OCDA > Dashboards > Data Manager - EDC.
Under Tasks on the left pane, click Permissions.
The Permissions dialog box appears.
Select No Access from the drop-down list of the relevant account.
Click OK.
Perform steps 3 through 6 for the Data Manager - Paper 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.
This dashboard includes the following tabbed pages:
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:
Displays reports detailing length of time since initiation or last monitoring visit.
The Sites to Monitor page includes the following reports:
Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)
Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)
Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)
Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)
Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)
Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)
Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)
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:
Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)
Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)
Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)
Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)
Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)
Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)
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:
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:
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 Principal Investigators for a Study-Site.
This page includes the following reports:
Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)
Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)
Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)
Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)
Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)
Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)
Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)
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:
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:
Displays reports on the current workload.
This eCRF Workload page includes the following reports:
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:
Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)
Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)
Average Days from Complete to Initially Approved (Report CDA-DM-325)
Average Days from Complete to Initially Verified (Report CDA-DM-330)
The Map of Study Sites page includes the following report:
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.
This dashboard includes the following tabbed pages:
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:
Displays reports on the current workload.
The eCRF Workload page includes the following reports:
Displays reports on discrepancy workload.
The Discrepancy Workload page includes the following reports:
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:
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:
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:
Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)
Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)
Average Days from Complete to Initially Approved (Report CDA-DM-325)
Average Days from Complete to Initially Verified (Report CDA-DM-330)
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:
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:
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.
This dashboard includes the following tabbed pages:
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:
Displays reports on the current workload.
The Page Workload page includes the following reports:
Displays reports on the discrepancy workload.
The Discrepancy Workload page includes the following reports:
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:
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:
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:
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
This dashboard includes the following tabbed pages:
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:
The KPI Summary page includes the following page-specific prompt:
Year Between: Supplemental prompt for those reports that include charts displaying data over year.
The KPI Summary page includes the following KPI Summary reports:
KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)
KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)
KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)
KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)
KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)
KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)
The Site Performance Summary page includes the following reports:
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:
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:
The Study-Site Map page includes the following report:
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
This dashboard includes the following tabbed pages:
Displays report links with the following attributes:
Section Title - Study-Region Performance Reports
Show Section Header - True
Show Section Title - True
Collapsible - False
The Overview page includes the following reports:
Study-Region List - Milestone Performance (Report CDA-CO-1109)
Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)
Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)
Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)
Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)
Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)
Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)
Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)
The Visit Reports & Follow Up Items page includes the following reports:
The Milestones and Schedule page includes the following report:
Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)
Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)
Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)
Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)
Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)
Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)
The KPI Summary page includes the following reports:
Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)
Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)
KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)
KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)
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:
The Initiating and Recruiting Study Regions page includes the following reports:
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:
The Map of Study Sites page includes the following report:
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.
This dashboard includes the following tabbed pages:
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:
Displays reports on studies actively initiating and actively recruiting.
The Initiating & Recruiting Studies page includes the following reports:
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:
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:
The KPI Summary page includes the following page-specific prompt:
Year Between: Supplemental prompt for those reports that include charts displaying data over year.
The KPI Summary page includes the following reports:
Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)
Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)
KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)
KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)
The Map of Study Sites page includes the following report:
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.
This dashboard includes the following tabbed pages:
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:
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:
Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)
Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)
Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)
Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)
Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)
Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)
Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)
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:
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:
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:
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:
Displays reports that list initiated sites / investigators enrolling no subjects, or only one subject.
The Non Performing Investigators page includes the following reports:
Displays reports on the distribution of top performing and non performing investigators.
The Site Performance page includes the following reports:
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:
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:
Displays a report that lists document tracking information for study documents.
The Site Document List page includes the following report:
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:
The Study Team page includes the following report:
The Map of Study Sites page includes the following report:
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:
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:
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
This dashboard includes the following tabbed pages:
Displays report links with the following attributes:
Section Title - Study-Region Performance Reports
Show Section Header - True
Show Section Title - True
Collapsible - False
The Overview page includes the following reports:
The Study-Site Milestones page includes the following reports:
Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)
Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)
Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)
Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)
Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)
Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)
Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)
The Screening Overview page includes the following reports:
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:
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:
The Sites to Monitor page includes the following reports:
Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)
Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)
Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)
Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)
Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)
Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)
Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)
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:
The Non Performing Investigators page includes the following reports:
The Site Performance page includes the following reports:
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:
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:
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:
The Site Document Metrics page includes the following reports:
The Map of Study-Sites page includes the following report:
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.
This dashboard includes the following tabbed pages:
Displays reports that contain identifying information for a study-site as well has high level overviews of milestones and subject recruitment and retention.
The Study-Site Overview page includes the following page-specific prompts:
Year and Month Between: Supplemental prompt for those reports that include charts displaying data over time.
The Study-Site Overview page includes the following reports:
Study-Site Subject Recruitment Narrative (Report CDA-CO-405)
Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)
Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)
Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)
Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)
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:
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:
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:
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:
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:
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:
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:
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:
Provides a snapshot of both Study-Site and Subject Protocol Deviations, broken out by Category.
The Protocol Deviations page includes the following reports:
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:
# Follow Up Items by Type (Multiple Study-Sites) (Report CDA-CO-810)
# Follow Up Items by Type for Study-Site (Report CDA-CO-801)
Approval & Verification Rates - Worst Performers (Report CDA-DM-350)
Average Days from Complete to Initially Approved (Report CDA-DM-325)
Average Days from Complete to Initially Verified (Report CDA-DM-330)
Average Duration in Categorized Discrepancy (Query) Review Status (Report CDA-DM-210)
Average Duration of Open Discrepancies (Queries) in Review Statuses (Report CDA-DM-215)
Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)
Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)
Counts of Discrepancies (Queries), by State and Review Status (Report CDA-DM-225)
Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)
Cumulative Enrollment and Early Term (Study-Site) (Report CDA-CO-418)
Cumulative Screening and Enrollment Bar (Study-Site) (Report CDA-CO-417)
Discrepancies (Queries) per Pages Entered - Top N (Report CDA-DM-255)
Discrepancies (Queries) per Subjects Enrolled - Top N (Report CDA-DM-250)
Discrepancy (Query) Overview with Ratios (Report CDA-DM-240)
Site Document Collection Cycle Times - Days Outstanding by Type (Report CDA-CO-606)
Document Collection Cycle Times (Study-Site) (Report CDA-CO-604)
Site Document Collection Cycle Times -Turn Around Time by Type (Report CDA-CO-607)
Enrollment Progress Over Time (Study Level) (Report CDA-CO-408)
Enrollment Progress Over Time (Study-Region Level) (Report CDA-CO-435)
Enrollment Progress Over Time (Study-Site Level) (Report CDA-CO-423)
Essential Documents Study-Site Risk Gauges (Report CDA-CO-625)
Initiated Study-Sites with Recruitment Counts (Report CDA-CO-412)
Key Performance Indicators Over Time - Monitoring (Region Manager) (Report CDA-CO-1112)
Key Performance Indicators Over Time (Executive View) (Report CDA-CO-902)
KPI Summary - CDP Complete to Site Initiated (Executive View) (Report CDA-CO-905)
KPI Summary - CDP Completed to Site Initiated (Region Manager View) (Report CDA-CO-1103)
KPI Summary - LSLV to Database Lock (Executive View) (Report CDA-CO-906)
KPI Summary - Protocol Approved to 1st Site Initiated (Executive View) (Report CDA-CO-907)
KPI Summary - Protocol Approved to 1st Subject Enrolled (Executive View) (Report CDA-CO-908)
KPI Summary - Site Visit Completed to Visit Report Completed (Executive View) (Report CDA-CO-909)
KPI Summary - Visit Report Completed to Approved (Region Manager View) (Report CDA-CO-1105)
KPI Summary - Visit Report Completed to Visit Report Approved (Executive View) (Report CDA-CO-910)
Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)
Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)
Low Approved to Entered Rate - Worst Performers (Report CDA-DM-335)
Low Verified to Entered Rate - Worst Performers (Report CDA-DM-340)
Median # Follow Up Items per Site for Study (Report CDA-CO-802)
Monitoring Report Approval - Turnaround Time vs. Goal (Report CDA-CO-813)
Monitoring Report Approval Turnaround Times (Report CDA-CO-817)
Monitoring Report Completion Turnaround Times (Report CDA-CO-820)
Monitoring Status Overview (Region Manager View) (Report CDA-CO-1101)
Monitoring Status Overview (Study Manager View) (Report CDA-CO-107)
Outstanding Follow up Items - Study Overview (Report CDA-CO-805)
Outstanding Follow up Items (Study Manager View) (Report CDA-CO-807)
Outstanding Follow up Items (Study-Region Overview) (Report CDA-CO-832)
Outstanding Follow up Items (Study-Site Overview) (Report CDA-CO-815)
Outstanding Monitoring Report Approvals (CRA View) (Report CDA-CO-814)
Outstanding Monitoring Report Approvals (Study Manager View) (Report CDA-CO-809)
Outstanding Monitoring Report Approvals (Study-Region) (Report CDA-CO-831)
Outstanding Monitoring Report Approvals (Study-Site) (Report CDA-CO-822)
Outstanding Monitoring Reports (CRA View) (Report CDA-CO-804)
Outstanding Monitoring Reports (Study-Region View) (Report CDA-CO-830)
Outstanding Monitoring Reports (Study-Site View) (Report CDA-CO-811)
Performance Metrics Summary Narrative - Site Visit (Report CDA-CO-1110)
Protocol Deviations (Study-Site) by Category (Report CDA-CO-1301)
Protocol Deviations (Subject) by Category (Report CDA-CO-1302)
Protocol Deviations Overview by Study-Site (Report CDA-CO-1305)
Protocol Deviation (Study-Site) Details (Report CDA-CO-1306)
Site Enrollment Performance Compared to Site Visit Frequency (Report CDA-CO-110)
Site Initiation Over Time Bar Chart (Study Region) (Report CDA-CO-307)
Site Recruitment Performance - Single Study (Report CDA-CO-416)
Site Recruitment Performance Charts (Executive View) (Report CDA-CO-436)
Sites to Monitor - Days Since Last Visit - Recruitment Detail View (Report CDA-CO-816A)
Sites to Monitor - Days Since Last Visit - Retention Detail View (Report CDA-CO-816B)
Sites to Monitor - Days Since Last Visit - Study Close Detail View (Report CDA-CO-816C)
Sites to Monitor - Days Since Last Visit - Summary View (Report CDA-CO-816D)
Sites with No Visits Since Initiation - Recruitment Detail View (Report CDA-CO-812A)
Sites with No Visits Since Initiation - Retention Detail View (Report CDA-CO-812B)
Sites with No Visits Since Initiation - Summary View (Report CDA-CO-812C)
Study Milestone with Indicators (Study Overview) (Report CDA-CO-101)
Study Region Milestones with Indicators - Data Management View (Report CDA-CO-1106A)
Study Region Milestones with Indicators - Recruitment Detail View (Report CDA-CO-1106B)
Study Region Milestones with Indicators - Retention Detail View (Report CDA-CO-1106C)
Study Region Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-1106D)
Study Region Milestones with Indicators - Study Close Detail View (Report CDA-CO-1106E)
Study Region Milestones with Indicators - Summary View (Report CDA-CO-1106F)
Study Region Milestones with Indicators (Single Study-Region) - Summary View (Report CDA-CO-1116F)
Study Region vs. Study - Site Start Up KPIs (Report CDA-CO-1111)
Study Regions with Red or Yellow Performance Flag - Recruitment Detail View (Report CDA-CO-1200B)
Study Regions with Red or Yellow Performance Flag - Retention Detail View (Report CDA-CO-1200C)
Study Regions with Red or Yellow Performance Flag - Site Start Up Detail View (Report CDA-CO-1200D)
Study Regions with Red or Yellow Performance Flag - Study Close Detail View (Report CDA-CO-1200E)
Study Regions with Red or Yellow Performance Flag - Summary View (Report CDA-CO-1200F)
Study Site Milestones with Indicators - Data Management View (Report CDA-CO-208A)
Study Site Milestones with Indicators - Monitoring View (Report CDA-CO-208B)
Study Site Milestones with Indicators - Recruitment Detail View (Report CDA-CO-208C)
Study Site Milestones with Indicators - Retention Detail View (Report CDA-CO-208D)
Study Site Milestones with Indicators - Site Start Up Detail View (Report CDA-CO-208E)
Study Site Milestones with Indicators - Study Close Detail View (Report CDA-CO-208F)
Study Site Milestones with Indicators - Summary View (Report CDA-CO-208G)
Study Sites Initiated, only One Subject Enrolled (Report CDA-CO-302)
Study-Region List - Milestone Performance (Report CDA-CO-1109)
Study-Region List and Recruitment Counts (Report CDA-CO-404)
Study-Site List by Recruitment Performance Group (Report CDA-CO-401)
Study-Site List with Indicators - Data Management View (Report CDA-CO-207A)
Study-Site List with Indicators - Monitoring View (Report CDA-CO-207B)
Study-Site List with Indicators - Recruitment Detail View (Report CDA-CO-207C)
Study-Site List with Indicators - Retention Detail View (Report CDA-CO-207D)
Study-Site List with Indicators - Site Start Up Detail View (Report CDA-CO-207E)
Study-Site List with Indicators - Study Close Detail View (Report CDA-CO-207F)
Study-Site List with Indicators - Summary View (Report CDA-CO-207G)
Study-Site Milestones with Indicators (CRA) - Monitoring View (Report CDA-CO-205A)
Study-Site Milestones with Indicators (CRA) - Recruitment Detail View (Report CDA-CO-205B)
Study-Site Milestones with Indicators (CRA) - Retention Detail View (Report CDA-CO-205C)
Study-Site Milestones with Indicators (CRA) - Site Start Up Detail View (Report CDA-CO-205D)
Study-Site Milestones with Indicators (CRA) - Study Close Detail View (Report CDA-CO-205E)
Study-Site Milestones with Indicators (CRA) - Summary View (Report CDA-CO-205F)
Study-Site Milestones with Indicators (CRA) - Data Management View (Report CDA-CO-205G)
Study-Site Milestones with Indicators (Single Study-Site) - Monitoring View (Report CDA-CO-203B)
Study-Site Milestones with Indicators (Single Study-Site) - Summary View (Report CDA-CO-203G)
Study-Site Subject Recruitment Narrative (Report CDA-CO-405)
Study-Sites with Red or Yellow Performance Flag (Report CDA-CO-204)
Subject Recruitment and Discontinuation Study Risk Gauges (Report CDA-CO-440)
Subject Recruitment and Discontinuation Study-Site Risk Gauges (Report CDA-CO-450)
Subject Retention Over Time (Study Level) (Report CDA-CO-501)
Subject Retention Over Time (Study-Site Level) (Report CDA-CO-510)
Subject Retention Over Time Chart (Study-Region Level) (Report CDA-CO-511)
Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)
Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)
Top Investigators Compared to All Investigators for Study, Total Enrollment (Report CDA-CO-702)
Top Investigators, % Planned Enrollment Completed (Report CDA-CO-700)
Visit Frequency Compared to Subject Enrollment (Report CDA-CO-819)
To locate a report, you need to select a dashboard and access a page that contains the report.
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.
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 |
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.
Table A-2 describes the columns in the # Follow Up Items by Type for Study-Site report.
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.
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 |
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.
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]" |
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.
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 |
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.
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 |
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.
Table Pivot table: rows=Study; columns=Categorized Review Status; cells=Average duration in Review Status, in days
CRA dashboard, Performance page
Data Manager - EDC dashboard, Performance page
Data Manager - Paper dashboard, Performance page
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 |
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).
Data Manager - EDC dashboard, Home page
Data Manager - EDC dashboard, Study Discrepancies (Queries) page
Data Manager - Paper dashboard, Home page
Table A-8 describes the columns in the Average Days Discrepancy (Query) Open report.
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.
Table Pivot table: rows=Study; columns=Review Status; cells=Average duration in Review Status Graph
Data Manager - EDC dashboard, Performance page
Data Manager - Paper dashboard, Performance page
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 |
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.
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" |
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.
Data Manager - EDC dashboard, Home page
Data Manager - EDC dashboard, Study Discrepancies (Queries) page
Data Manager - Paper dashboard, Home page
Table A-11 describes the columns in the Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank report.
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.
Table Pivot table: rows=Study; columns=Categorized Review Status; cells=#Open Discrepancies (Queries) Graph attached to the Pivot table
Data Manager - EDC dashboard, Discrepancy (Query) Workload page
Data Manager - Paper dashboard, Discrepancy (Query) Workload page
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 |
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.
Data Manager - EDC dashboard, Discrepancy (Query) Workload page
Data Manager - Paper dashboard, Discrepancy (Query) Workload page
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 |
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.
Data Manager - EDC dashboard, Home page
Data Manager - EDC dashboard, Study Discrepancies (Queries) page
Data Manager - Paper dashboard, Home page
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 |
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.
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 |
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.
Study-Site Overview dashboard, Study-Site Overview page
Study-Site Overview dashboard, Screening and Recruitment Overview page
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) |
Displays gauges for data quality risk indicators at the study level.
Displays gauges for data quality risk indicators at the study-site level.
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.
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" |
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.
Study Manager dashboard, Study Manager Overview page
Executive Overview dashboard, Study List
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" |
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.
Table A-19 describes the columns in the Discrepancies (Queries) per Pages Entered - Top N report.
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.
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 |
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.
Data Manager - EDC dashboard, Discrepancy (Query) Workload page
Data Manager - Paper dashboard, Discrepancy (Query) Workload page
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 |
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.
Study Overview dashboard, Site Document Metrics page
Study-Site Overview dashboard, Site Document Metrics page
Study-Region Overview dashboard, Study-Site Document Metrics page
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) |
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.
Study Overview dashboard, Site Document Metrics page
Study-Site Overview dashboard, Site Document Metrics page
Study-Region Overview dashboard, Study-Site Document Metrics page
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 |
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.
Study Overview dashboard, Site Document Metrics page
Study-Site Overview dashboard, Site Document Metrics page
Study-Region Overview dashboard, Study-Site Document Metrics page
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) |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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) |
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.
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} |
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.
Table A-31 describes the columns in the Enrollment Progress Over Time (Study-Site Level) report.
Displays gauges for essential document risk indicators at the study level.
Displays gauges for essential document risk indicators at the study-site level.
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.
Executive dashboard, Map of Study-Sites, Region manager dashboard, Study-Region Overview dashboard, Overview page
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 |
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.
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
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" |
Lists initiated study-sites and their progress toward recruitment goals, as well as details including days since initiation and days since latest enrollment.
CRA dashboard, Initiating and Recruiting Study-Sites page
Study-Region Overview dashboard, Recruitment Overview page
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 |
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.
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 |
Displays gauges for issue management risk indicators at the study level.
Displays gauges for issue management risk indicators at the study-site level.
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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
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") |
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.
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]") |
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.
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)") |
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.
Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page
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" |
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.
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)]") |
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.
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)]") |
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.
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)]") |
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.
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") |
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.
Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page
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" |
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.
Study Manager dashboard, KPI Summary Region Manager dashboard, KPI Summary dashboard, KPI Summary Region Manager dashboard, KPI Summary page
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" |
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.
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]" |
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.
Subject.Subject ID
Discrepancies.Visit Name
Discrepancies.CRF Name
Discrepancies.Validation Procedure Name
Discrepancies.Current Review Status
Discrepancies.Discrepancy State
You can navigate to this report from the following reports:
Counts of Categorized Open Discrepancies (Queries), by Review Status (Report CDA-DM-220)
Count of Currently Open Discrepancies (Queries) by CRF and Type - Top N by Rank (Report CDA-DM-230)
Counts of Open Multivariate Discrepancies (Queries), by Procedure (Report CDA-DM-235)
Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)
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 |
Lists follow up items, including type, comments, and key dates.
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 |
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.
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 |
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.
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 |
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.
Table A-55 describes the columns in the Low Approved to Entered Rate - Worst Performers report.
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.
Table A-56 describes the columns in the Low Verified to Entered Rate - Worst Performers report.
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.
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 |
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.
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 |
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.
Study Manager dashboard, Monitoring Metrics page
Region Manager dashboard, Visit Reports & Follow Up Items page
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 |
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.
Study Manager dashboard, Monitoring Metrics page
CRA dashboard, Monitoring Metrics page
Region Manager dashboard, Visit Reports & Follow Up Items page
Monitoring Metrics page
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 |
Shows count of outstanding visit reports, visit report approvals and follow up items
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") |
Shows count of outstanding visit reports, visit report approvals and follow up items
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") |
Pie chart that shows count of studies. Column selector allows user to view by Therapeutic Area, Program, or Phase.
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
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 |
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.
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)]" |
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.
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 |
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.
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 |
Lists the outstanding follow up items. This report indicates which active issues are occurring during monitoring visits, and how long they've been open.
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 |
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.
Study Manager dashboard, Monitoring Metrics page
Region Manager dashboard, Visit Reports & Follow Up Items page
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 |
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.
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 |
Lists all follow up items that have not been completed. This report indicates which follow up items need to be resolved.
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 |
Lists all monitoring reports awaiting approval. This report indicates which monitoring reports require an action: review and approval.
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 |
Lists the monitoring reports that have been completed but not yet approved. This report indicates which monitoring reports require approval.
Study Manager dashboard, Monitoring Metrics page
Region Manager dashboard, Visit Reports & Follow Up Items page
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 |
Lists all monitoring reports awaiting approval in the study region. This report indicates which monitoring reports require an action: review and approval.
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 |
Lists all monitoring reports awaiting approval at the study-site. This report indicates which monitoring reports require an action: review and approval.
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 |
Lists all monitoring reports awaiting completion. This report indicates which monitoring reports need to be completed and submitted for approval.
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 |
Lists all monitoring reports awaiting completion at the study region. This report indicates which monitoring reports need to be completed and submitted for approval.
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 |
Lists all monitoring reports awaiting completion at the study-site. This report indicates which monitoring reports need to be completed and submitted for approval.
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 |
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.
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 |
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.
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" |
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.
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 |
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.
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 |
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.
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 |
Displays the pie chart with the number of Study-Site related Protocol Deviations for a Study, by category.
Displays the pie chart with the number of Subject related Protocol Deviations for a Study, by category.
Displays the tile with the number of Study-Site related Protocol Deviations for a Study.
Displays the tile with the number of Subject related Protocol Deviations for a Study.
Lists the number of times a Study-Site has had either a Study-Site or Subject related Protocol Deviation for a particular Study.
Displays the details of the Study-Site related Protocol Deviations for a Study.
Displays the details of Subject related Protocol Deviations for a Study.
Lists details for the different versions of a protocol, including approved date, version number and comments.
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.
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.
Study Overview dashboard, Screening Overview page
Study-Region Overview dashboard, Screening Overview page
Displays (by site) the number of subjects who failed screening. This report indicates which screen failure reasons account for the most screen failures.
Study Overview dashboard, Screening Overview page
Study Region Overview dashboard, Screening Overview page
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 |
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.
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 |
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.
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" |
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.
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 |
Displays cumulative screening and enrollment by study region. This report indicates how each region in a study is progressing toward recruitment goals.
Study Overview dashboard, Screening Overview page
Study Region Overview dashboard, Screening Overview page
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.
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 |
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.
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" |
Line-bar graph that shows the number of sites initiated compared to the number of sites planned for a Study-Region.
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" |
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.
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 |
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.
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.
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 |
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.
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) |
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.
Study-Site Overview dashboard, Monitoring Metrics page
Region Manager dashboard, Visit Reports & Follow Up Items page
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) |
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.
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) |
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.
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") |
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.
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 |
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.
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))) |
NA |
Navigate to detail |
NA |
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.
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))) |
NA |
Navigate to detail |
NA |
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.
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 |
Navigate to detail |
NA |
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.
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 |
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.
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))) |
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.
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 |
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.
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 |
Displays a gauge showing how many subjects have been enrolled in the study compared to the number of subjects planned for the study.
Displays a summary of identifying information for a study, including Study #, Program, Product and Study Status.
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 |
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.
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 |
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.
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)]" |
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.
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))) |
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.
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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Navigate to Detail |
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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.
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))) |
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.
Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study.
Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study.
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.
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" |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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" |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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)
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)") |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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 |
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.
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" |
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.
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" |
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.
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))) |
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.
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))) |
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.
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))) |
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.
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))) |
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.
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" |
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.
Study Overview dashboard, Non Performing Investigators page
Study Region Overview dashboard, Non-Performing Investigators page
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 |
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.
Study Overview dashboard, Non Performing Investigators page
Study Region Overview dashboard, Non-Performing Investigators page
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 |
Lists all of the team members for a study.
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 |
|
"Study Team Member"."Email" |
Study Team Member |
Team Member Active |
"Study Team Member"."Team Member Active" |
Displays a summary of identifying information for a study-region, including Region Name, Study #, and Study-Region Status.
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" |
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.
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))) |
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.
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 |
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.
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))) |
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.
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]" |
Lists all study regions and recruitment counts. This report indicates how well each region is progressing toward recruitment goals.
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 |
Lists all of the team members for a study-region.
You can navigate to the following reports from this report:
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 |
|
"Study-Region Team Member"."Email" |
Study-Region Team Member |
Team Member Active |
"Study-Region Team Member"."Team Member Active" |
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.
Displays a summary of identifying information for a study-site, including Study #, Program, Study-Site ID, Principal Investigator and Study-Site Status.
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 |
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.
Study Overview dashboard, Site Performance page
Study-Region Overview dashboard, Site Performance page
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 |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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" |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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" |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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))) |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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))) |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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))) |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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))) |
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.
Study Region Overview dashboard, Study-Site Milestones page
CRA, Study-Site Milestones page
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" |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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" |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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))) |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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))) |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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))) |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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" |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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))) |
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.
CRA dashboard, Study-Site Milestones page
Study Region Overview dashboard, Study-Site Milestones page
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" |
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.
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" |
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.
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" |
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.
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))) |
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.
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))) |
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.
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))) |
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.
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))) |
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.
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))) |
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.
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.
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.
Displays the RACT (Risk Assessment Categorization Tool) score, broken out by category for a Study-Site.
Displays the tile with the RACT (Risk Assessment Categorization Tool) score for a Study-Site.
Map of multiple risk indicators for the study-sites in the study.
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.
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 |
Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.
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 |
Lists all of the team members for a study-site.
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 |
|
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 |
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.
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" |
Shows the distribution of subject enrollment by region. This report indicates which regions are contributing the most to recruitment.
Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study level.
Displays gauges for subject recruitment and discontinuation risk indicators (Screen Failure Rate and Withdrawal Rate) at the study-site level.
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.
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 |
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.
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" |
Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.
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) |
Displays a summary of retention information for a study. This report indicates planned recruitment vs. actual retention information for a single study.
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 |
Displays a summary of retention information for a study-region. This report indicates planned recruitment vs. actual retention information for a single study-region.
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" |
Displays a summary of retention information for a study-site. This report indicates planned recruitment vs. actual retention information for a single study-site.
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 |
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.
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) |
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.
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) |
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.
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} |
Displays the number of subjects enrolled per month. This report indicates the pattern of enrollment over time at a study-site.
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.
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 |
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.
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 |
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.
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 |
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.
The following reports reference this report:
Key Paper processing volumes (Report CDA-DM-405)
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 |
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.
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
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 |
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.
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
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) |
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.
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
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) |
Shows cumulative actual enrollment by region. This report indicates which regions are contributing the most to recruitment.
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.
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 |
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.
Study Overview dashboard, Monitoring Metrics page
Study Overview dashboard, Monitoring Metrics page
Region Manager dashboard, Monitoring Metrics page
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 |
Displays (by withdrawn reason) the number of subjects who terminated early. This report indicates which withdrawn reasons account for the most early terminations.
Study Overview dashboard, Retention Overview page
Study-Site Overview dashboard, Retention Overview page
Study-Region Overview dashboard, Retention Overview page
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 |
Displays (by site) the number of early terminations. This report indicates which withdrawn reasons account for the most early terminations.
Study Overview dashboard, Retention Overview page
Study-Region Overview dashboard, Retention Overview page
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 |