| Oracle® Clinical Development Analytics User and Administrator Guide Release 2.0.0.2 Part Number E18162-03 |
|
|
View PDF |
| Oracle® Clinical Development Analytics User and Administrator Guide Release 2.0.0.2 Part Number E18162-03 |
|
|
View PDF |
This section describes predefined dashboards and reports delivered with Oracle Clinical Development Analytics (OCDA):
See Also:
OCDA 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.
OCDA includes the following dashboards:
Log in to OCDA, and select the dashboard you want to view. For more information, refer to Accessing Oracle Clinical Development Analytics.
This dashboard can be accessed by a Study Manager or Clinical Research Associate (CRA). It provides some initial reports related to document management and related cycle times.
This dashboard includes the following prompts, which are common to all its pages:
Program: Lists the names of the Programs that own a Study.
Product Name: Lists the names of the Products that own a Study.
Study: Lists Studies within a Program or Product.
Study Status: Lists the Statuses of a Study.
Study Region: Lists the Regions for a Study.
Study Region Status: Lists the Statuses of a Study Region.
Study-Site ID #: Lists Sites within a Study, by site number.
Site Name: Lists the name of the center or institution for a Study-Site.
Study-Site Status: Lists the Statuses of a Study-Site.
Activity Type: Lists types of clinical documents collected for a Study or at a Study-Site.
Document Sent Date: Indicates the date a Document was Sent.
Document Received Date: Indicates the date a Document was Received.
Note:
The following prompts only apply to Study-Site documents. The dataset returned from filtering on one of these prompts will only include Study-Site documents.Program
Product Name
Study
Study Status
Study Region
Region Status
Study-Site ID #
Site Name
Study-Site Status
This dashboard includes the following tabbed pages:
Displays reports that lists clinical documents, as well as a chart summarizing outstanding documents.
This page includes the following reports:
This dashboard can be accessed by a Study Manager or CRA. It provides some initial reports related to site start up and recruitment.
This dashboard includes the following prompts, which are common to all its pages:
Program: Lists the names of the Programs that own a Study.
Product Name: Lists the names of the Products that own a Study.
Study: Lists Studies within a Program or Product.
Study Status: Lists the Statuses of a Study.
Study Region: Lists the Regions for a Study.
Study Region Status: Lists the Statuses of a Study Region.
Study-Site ID #: Lists Sites within a Study, by site number.
Site Name: Lists the name of the center or institution for a Study-Site.
Principal Investigator: Lists the Principal Investigators for a Study-Site.
Study-Site Status: Lists the Statuses of a Study-Site.
This dashboard includes the following tabbed pages:
Displays a report that provides site status by region.
This page includes the following reports:
Displays a report that compares sites based on progress toward site enrollment goals and contribution toward study recruitment goals.
This page includes the following reports:
Displays a report related to subject screening.
This page includes the following reports:
Displays reports related to screening failures.
This page includes the following reports:
Displays reports related to subject enrollment.
This page includes the following reports:
Displays reports related to subject randomization.
This page includes the following reports:
This dashboard can be accessed by a Study Manager or CRA. It provides some initial reports related to a study or region overall and is intended as a starting point for an implementation.
This dashboard includes the following prompts, which are common to all its pages:
Program: Lists the names of all Programs.
Product Name: Lists the names of all Products.
Study: Lists Studies within a Program or Product.
Study Status: Lists the Statuses of a Study.
Study Region: Lists the Regions for a Study.
Study Region Status: Lists the Statuses of a Study Region.
This dashboard includes the following tabbed pages:
Displays reports related to site readiness and enrollment.
This page includes the following reports:
This is the subject retentian and early termination dashboard for a Study Manager or CRA. It provides some initial reports related to site start up and recruitment.
This dashboard includes the following prompts, which are common to all its pages:
Program: Lists the names of the Programs that own a Study.
Product Name: Lists the names of the Products that own a Study.
Study: Lists Studies within a Program or Product.
Study Status: Lists the Statuses of a Study.
Study Region: Lists the Regions for a Study.
Study Region Status: Lists the Statuses of a Study Region.
Study-Site ID #: Lists Sites within a Study, by site number.
Site Name: Lists the name of the center or institution for a Study-Site.
Principal Investigator: Lists the Principal Investigators for a Study-Site.
Study-Site Status: Lists the Statuses of a Study-Site.
This dashboard includes the following tabbed pages:
Displays reports related to subject retention.
This page includes the following reports:
Displays reports related to subject early termination.
This page includes the following reports:
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 includes the following prompts, which are common to all its pages:
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.
Study: Lists Studies within a Program.
Study Site: Lists Sites within a Study.
This dashboard includes the following tabbed pages:
Displays reports on the current workload.
This page includes the following reports:
Displays reports on key performance rates.
The Key Rates page includes the following reports:
Displays reports on key cycle times.
The Performance page includes the following reports:
Average Duration in Categorized Discrepancy Review Status (Report CDA-DM-210)
Average Duration of Open Discrepancies in Review Statuses (Report CDA-DM-215)
Average Days from Complete to Initially Approved - Top 25 (Report CDA-DM-325)
Average Days from Complete to Initially Verified - Top 25 (Report CDA-DM-330)
This dashboard is the Data Management dashboard for EDC studies. It can be accessed by a Data Manager (DM), and provides numerous reports and charts to monitor performance of EDC studies.
The DM EDC dashboard includes these prompts, which are common to all its pages:
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.
Study: Lists Studies within a Program.
Study Site: Lists Sites within a Study.
This dashboard includes the following tabbed pages:
Displays key study based reports.
The Home page includes the following reports:
Average Duration of Currently Open Discrepancies, by Site (Report CDA-DM-205)
Count of Currently Open Discrepancies by CRF and Type - Top 10 by Rank (Report CDA-DM-230)
Counts of Open Multivariate Discrepancies, by Procedure (Report CDA-DM-235)
Approval & Verification Rates - Worst 25 (Report CDA-DM-350)
Displays reports on the current workload.
The eCRF 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 reports:
Displays reports on the key performance rates.
The Key Rates page includes the following reports:
Displays reports on the key cycle times.
The Performance page includes the following reports:
Average Duration in Categorized Discrepancy Review Status (Report CDA-DM-210)
Average Duration of Open Discrepancies in Review Statuses (Report CDA-DM-215)
Average Days from Complete to Initially Approved - Top 25 (Report CDA-DM-325)
Average Days from Complete to Initially Verified - Top 25 (Report CDA-DM-330)
Displays reports on the key study based discrepancy indicators.
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 a Data Manager (DM), and provides numerous reports and charts to monitor performance of Paper studies.
This dashboard includes the following prompts, which are common to all its pages:
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.
Study: Lists Studies within a Program.
Study Site: Lists Sites within a Study.
This dashboard includes the following tabbed pages:
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 reports:
Displays reports on the key performance rates.
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:
OCDA includes the following reports:
Approval & Verification Rates - Worst 25 (Report CDA-DM-350)
Average Days from Complete to Initially Approved - Top 25 (Report CDA-DM-325)
Average Days from Complete to Initially Verified - Top 25 (Report CDA-DM-330)
Average Duration in Categorized Discrepancy Review Status (Report CDA-DM-210)
Average Duration of Currently Open Discrepancies, by Site (Report CDA-DM-205)
Average Duration of Open Discrepancies in Review Statuses (Report CDA-DM-215)
Count of Currently Open Discrepancies by CRF and Type - Top 10 by Rank (Report CDA-DM-230)
Counts of Categorized Open Discrepancies, by Review Status (Report CDA-DM-220)
Counts of Discrepancies, by State and Review Status (Report CDA-DM-225)
Counts of Open Multivariate Discrepancies, by Procedure (Report CDA-DM-235)
Discrepancies per Pages Entered - Top 25 (Report CDA-DM-255)
Discrepancies per Subjects Enrolled - Top 25 (Report CDA-DM-250)
Document Collection Cycle Times - Days Outstanding by Type (Report 3SS04-1b)
Document Collection Cycle Times -Turn Around Time by Type (Report 3SS04-1c)
Listing of Subject-Pages, Awaiting EDC Processing (Report CDA-DM-310)
Listing of Subject-Pages, Awaiting Paper Processing (Report CDA-DM-410)
Paper Processing Cycle Times - 25 Longest (Report CDA-DM-415)
Planned Sites vs. Sites Screening & Enrolling Chart (Bottom 10) (Report 3SS02-1d)
Planned Sites vs. Sites Screening & Enrolling Chart (Top 10) (Report 3SS02-1b)
Screen Failure Reason by Site Chart (Top 10 # Screen Failures) (Report 4PR02-1c)
Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)
Summary of Subjects Awaiting Paper Processing (Report CDA-DM-420)
Withdrawn Reason Overview Chart (Top 10 # Early Terms) (Report 8SDP-25)
To locate a report, you need to select a dashboard and access a page that contains the report.
Identifies the top 25 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-1 describes the columns in the Approval & Verification Rates - Worst 25 report:
Table A-1 Approval & Verification Rates - Worst 25 Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
NA |
Study-Site.Study Name |
|
% of Entry-Complete eCRFs |
Approved |
Received CRFs.% eCRFs Approved / Entry Complete |
|
% of Entry-Complete eCRFs |
Verified |
Received CRFs.% eCRFs Verified / Entry Complete |
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.
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's CRA. When compared across studies, it can be an indicator of study team inefficiencies.
Identifies the average number of days discrepancies 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. 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 EDC dashboard, Performance page
DM EDC dashboard, Performance page
DM Paper dashboard, Performance page
Table A-4 describes the columns in the Average Duration in Categorized Discrepancy Review Status report:
Table A-4 Average Duration in Categorized Discrepancy Review Status Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
Discrepancies |
State |
Discrepancies.Discrepancy State |
|
Discrepancies |
Categorized Review Status |
Discrepancy Review Statuses.Discrepancy Review Status |
|
Discrepancies |
Average duration in Review Status |
Discrepancy Review Statuses.Avg # Days Discrepancy Ever in Review Status |
|
Discrepancies |
# Discrepancies |
Discrepancies.# Total Discrepancies |
Identifies distribution of open discrepancies, by the number of days they have been open.
This report indicates which sites have the oldest currently open discrepancies.
CRA EDC dashboard, Home page
DM EDC dashboard, Home page
DM EDC dashboard, Study Discrepancies page
DM Paper dashboard, Home page
Identifies the average number of days discrepancies are open within a review status.
This report indicates the average length of time that discrepancies 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 attached to the Pivot table: Horizontal bar, 2D stacked rectangle
CRA EDC dashboard, Performance page
DM EDC dashboard, Performance page
DM Paper dashboard, Performance page
Table A-6 describes the columns in the Average Duration of Open Discrepancies in Review Statuses report:
Table A-6 Average Duration of Open Discrepancies in Review Statuses Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
Discrepancies |
Review Status |
Discrepancy Review Statuses.Discrepancy Review Status |
|
Discrepancies |
Average duration in Review StatusFoot 1 |
Discrepancy Review Statuses.Avg # Days Open Discrepancy Ever in Review Status |
Footnote 1 Conditional Formatting Threshold: Yellow - between 30 and 60 Conditional Formatting Threshold: Red - greater than or equal to 60
For each study, lists all sites (grouped by region) and the percentage of the study's total screening, enrollment, and randomization the site is responsible for. Also includes the percentage of enrollment completed compared to number planned at site.
This report indicates which sites are responsible for the most subjects screened, enrolled and randomized. It also specifies the percentages of the study's planned enrollment and total enrollment is the site responsible for.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID #
Study-Site.Site Name
Study-Site.Study-Site Status
Table A-7 describes the columns in the Comparative Site Enrollment Status Table report:
Table A-7 Comparative Site Enrollment Status Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID # |
Study-Site.Study-Site ID # |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
NA |
% Of Total Screened In Study |
Study-Site Metrics.% Of Total Screened In Study |
|
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 |
% Of Total Randomized In Study |
Study-Site Metrics.% Of Total Randomized In Study |
Identifies the top 10 CRFs which are producing the most discrepancies.
A CRF which is associated with a high number of discrepancies 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 created.
DM EDC dashboard, Home page
DM EDC dashboard, Study Discrepancies page
DM Paper dashboard, Home page
Identifies how many discrepancies are open, by review status.
This report indicates the number of open discrepancies, within a number of categorized review groups. This information can be used to identify which functional team or area has the most outstanding discrepancies, which could indicate a resource shortage.
Table
Pivot table: rows=Study; columns=Categorized Review Status; cells=#Open Discrepancies
Graph attached to the Pivot table
CRA EDC dashboard, Discrepancy Workload page
DM EDC dashboard, Discrepancy Workload page
DM Paper dashboard, Discrepancy Workload page
Table A-9 describes the columns in the Counts of Categorized Open Discrepancies, by Review Status report:
Table A-9 Counts of Categorized Open Discrepancies, by Review Status Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
Discrepancies |
Categorized Review Status |
Discrepancy Review Statuses.Discrepancy Review Status |
|
Discrepancies |
# Open Discrepancies |
Discrepancies.# Total Discrepancies |
Identifies the number of open and closed discrepancies, by review status.
This report indicates which review states are creating the largest volumes of discrepancies. This information can be used to identify high discrepancy volumes with a review state which may indicate lack of resource or process inefficiency.
Table A-10 describes the columns in the Counts of Discrepancies, by State and Review Status report:
Table A-10 Counts of Discrepancies, by State and Review Status Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study |
Study-Site.Study Name |
|
Discrepancies |
Review Status |
Discrepancy Review Statuses.Discrepancy Review Status |
|
Discrepancies |
State |
Discrepancies.Discrepancy State |
|
Discrepancies |
# Discrepancies |
Discrepancies.# Total Discrepancies |
Identifies the distribution of discrepancies, by validation procedure.
This report indicates which validation procedures are creating the most discrepancies. A procedure which is associated with a high number of discrepancies 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 created.
DM EDC dashboard, Home page
DM EDC dashboard, Study Discrepancies page
DM Paper dashboard, Home page
Identifies the rate of discrepancies per pages entered.
This report displays the top 25 studies and associated sites which have the highest numbers of discrepancies per page. This information can be used to identify poor performance across studies and across sites.
Identifies the rate of discrepancies per subjects enrolled.
This report identifies the top 25 studies and associated sites which have the highest numbers of discrepancies per enrolled subject. This information can be used to identify poor performance across studies and across sites.
Identifies how many discrepancies are open and closed. In addition, the report also shows ratios of the number of discrepancies 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.
CRA EDC dashboard, Discrepancy Workload page
DM EDC dashboard, Discrepancy Workload page
DM Paper dashboard, Discrepancy Workload page
Table A-14 describes the columns in the Discrepancy Overview with Ratios report:
Table A-14 Discrepancy Overview with Ratios Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
NA |
# Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
|
NA |
# CRFs Present |
Received CRFs.# CRFs Present |
|
# Discrepancies |
OpenFoot 1 |
Discrepancies.# Open Discrepancies |
|
# Discrepancies |
Closed |
Discrepancies.# Closed Discrepancies |
|
# Discrepancies |
TotalFoot 2 |
Discrepancies.# Total Discrepancies |
|
Discrepancies per Received CRF |
Open |
Study-site Metrics.Open Discrepancies per CRF |
|
Discrepancies per Received CRF |
Total |
Study-site Metrics.Total Discrepancies per CRF |
Footnote 1 Conditional Formatting Threshold: Yellow - between 5 and 9 Conditional Formatting Threshold: Red - greater than or equal to 10
Footnote 2 Conditional Formatting Threshold: Yellow - between 5 and 10 Conditional Formatting Threshold: Red - greater than or equal to 11
Displays (by document type) the average days a document has been outstanding.
This report indicates how long have documents been outstanding. It also indicates the documents that lag the most.
Lists (by program, study, and region) all documents collected, the number of days from sent to received, and the number of days outstanding if not received.
The report indicates how long have documents been outstanding, and how long does it typically take to receive documents. It also indicates the documents that lag the most.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Region.Region Name
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site.Study-Site Status
Table A-16 describes the columns in the Document Collection Cycle Times Table report:
Table A-16 Document Collection Cycle Times Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Region |
Region Name |
Region.Region Name |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
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 |
# 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.
Lists (by program, study, region and site) all documents collected, including document status, sent date, received date, and comments.
This report indicates which documents are missing. It also indicates the essential documents are missing for those sites that are not ready to enroll.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Study-Site Status
Study-Site.Principal Investigator
Study-Site Team Member.Full Name
Study-Site Team Member.Role
Table A-18 describes the columns in the Documents List report:
Table A-18 Documents List Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site. |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site Team Member |
Full Name |
Study-Site Team Member.Full Name |
|
Study-Site Team Member |
Role |
Study-Site Team Member.Role |
|
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 |
Displays (by study) the number of subjects enrolled.
This report indicates the progress each region is making towards 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.
CO - Site and Recruitment Overview dashboard, Enrollment Overview page
CO - Study and Region Overview dashboard, Enrollment Overview page
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.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site Team Member.Full Name
Study-Site Team Member.Role
Study-Site.Study-Site Status
Table A-20 describes the columns in the Enrollment Overview By Site report:
Table A-20 Enrollment Overview By Site Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site Team Member |
Full Name |
Study-Site Team Member.Full Name |
|
Study-Site Team Member |
Role |
Study-Site Team Member.Role |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
NA |
# Subjects Planned for Study-Site |
Study-site Metrics.# Subjects Planned for Study-Site |
|
NA |
# Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
Displays (by month) the cumulative number of subjects enrolled compared to the number of subjects planned to be enrolled.
This report indicates how much progress is being made towards planned enrollment targets.
Table A-21 describes the columns in the Enrollment Progress Over Time report:
Table A-21 Enrollment Progress Over Time Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
100% Planned Site Enrollment |
Max(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))) |
|
NA |
90% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.9 ) |
|
NA |
75% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.75 ) |
|
NA |
50% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.5 ) |
|
NA |
# Subjects Enrolled |
'- Study-site Metrics."# Subjects Enrolled" |
|
NA |
Year and Month |
Date."Year and Month" |
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-22 describes the columns in the Key Cycle Times for Paper Studies report:
Table A-22 Key Cycle Times for Paper Studies Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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 EntryFoot 1 |
Received CRFs.Avg # Days from pCRF Visit to First Entry |
|
Average Days |
First Entry to Second Entry CompleteFoot 2 |
Received CRFs.Avg # Days from pCRF First Entry to Second Entry Complete |
|
Average Days |
Visit to Entry CompleteFoot 3 |
Received CRFs.Avg # Days from pCRF Visit to Entry Complete |
|
Average Days |
Entry Complete to Soft Locked |
Received CRFs.Avg # Days from pCRF Entry Complete to Soft Locked |
Footnote 1 Conditional Formatting Threshold: Yellow - between 30 and 59 Conditional Formatting Threshold: Red - greater than or equal to 60
Footnote 2 Conditional Formatting Threshold: Yellow - between 3 and 9 Conditional Formatting Threshold: Red - greater than or equal to 10
Footnote 3 Conditional Formatting Threshold: Yellow - between 33 and 70 Conditional Formatting Threshold: Red - greater than or equal to 70
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-23 describes the columns in the Key EDC Cycle Times report:
Table A-23 Key EDC Cycle Times Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
NA |
Study-Site.Program |
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
NA |
#Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
|
NA |
# Entry CompleteFoot 1 |
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 |
Received CRFs.Avg # Days from eCRF Complete to Soft Locked |
Footnote 1 Conditional Formatting Threshold: Yellow - between 10 and 20 Conditional Formatting Threshold: Red - greater than 20
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-24 describes the columns in the Key EDC processing volumes report:
Table A-24 Key EDC processing volumes Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study Name |
Study-Site.Study Name |
|
NA |
#Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
|
NA |
# Open Discrepancies |
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 |
Received CRFs.# eCRFs Soft Locked |
|
# eCRFs |
Hard Locked |
Received CRFs.# eCRFs Hard Locked |
|
0f Entry-Complete eCRFs |
Approved |
Received CRFs.% eCRFs Approved / Entry Complete |
|
0f Entry-Complete eCRFs |
VerifiedFoot 1 |
Received CRFs.% eCRFs Verified / Entry Complete |
|
0f Entry-Complete eCRFs |
Soft Locked |
Received CRFs.% eCRFs Soft Locked / Entry Complete |
|
0f Entry-Complete eCRFs |
Hard Locked |
Received CRFs.% eCRFs Hard Locked / Entry Complete |
|
NA |
Navigate to Detail |
Not Applicable.Navigate |
Footnote 1 Conditional Formatting Threshold: Yellow - between 30 and 50 Conditional Formatting Threshold: Red - less than or equal to 30
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-25 describes the columns in the Key Paper processing volumes report:
Table A-25 Key Paper processing volumes Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study |
Study-Site.Study Name |
|
NA |
#Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
|
NA |
# Open Discrepancies |
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 |
Received CRFs.# pCRFs Soft Locked |
|
# CRFs |
Hard Locked |
Received CRFs.# pCRFs Hard Locked |
|
0f Entry-Complete CRFs |
Soft Locked |
Received CRFs.% pCRFs Soft Locked / Entry Complete |
|
0f Entry-Complete CRFs |
Hard Locked |
Received CRFs.% pCRFs Hard Locked / Entry Complete |
|
NA |
Navigate to Detail |
Not Applicable.Navigate |
Lists open discrepancies and associated details, and is used as a detailed drill down report to list all discrepancies and associated details.
This report can be used to explore the open discrepancies, and identify any patterns or clusters through the use of sorting.
CRF.Name
Study-Site.Site Name
Study-Site.Program
Study-Site.Study Name
Subject.Subject ID
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, by Review Status (Report CDA-DM-220)
Count of Currently Open Discrepancies by CRF and Type - Top 10 by Rank (Report CDA-DM-230)
Counts of Open Multivariate Discrepancies, by Procedure (Report CDA-DM-235)
Summary of Subjects Awaiting EDC Processing (Report CDA-DM-320)
Table A-26 describes the columns in the List Discrepancy Details report:
Table A-26 List Discrepancy Details Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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 OpenFoot 1 |
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 |
Discrepancy ID |
Discrepancies.Discrepancy ID |
|
Discrepancy |
Procedure Name |
Discrepancies.Validation Procedure Name |
|
Discrepancy |
Review Status |
Discrepancies.Current Review Status |
|
Discrepancy |
Comment Text |
Discrepancies.Comment Text |
|
Discrepancy |
Sent in DCF |
Discrepancies.Sent in DCF |
|
Discrepancy |
State |
Discrepancies.Discrepancy State |
Footnote 1 Conditional Formatting Threshold: Yellow - between 5 and 10 Conditional Formatting Threshold: Red - greater than or equal to 10
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.
CRF.Name
Study-Site.Site Name
Study-Site.Program
Study-Site.Study Name
Subject.Subject ID
Table A-27 describes the columns in the Listing of Subject-Pages, Awaiting EDC Processing report:
Table A-27 Listing of Subject-Pages, Awaiting EDC Processing Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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-28 describes the columns in the Listing of Subject-Pages, Awaiting Paper Processing report:
Table A-28 Listing of Subject-Pages, Awaiting Paper Processing Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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.Identifies sites where verification has been slow.
This report displays the top 25 sites whose verification rates are less than 50% of those pages entered. This information can be used to identify CRA resource shortfalls.
Displays (by document category) the number of documents currently outstanding. Each bar in the report is stacked by document type.
This report indicates the documents that are missing.
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 worklog to drive activity.
Table A-32 describes the columns in the Pages Awaiting Entry Completion - Sites with 25 largest backlogs report:
Table A-32 Pages Awaiting Entry Completion Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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 25 studies with the longest cycle times for paper processing. This information can be used to highlight process inefficiencies and potential resource shortfalls.
Table A-33 describes the columns in the Paper Processing Cycle Times - 25 Longest report:
Table A-33 Paper Processing Cycle Times - 25 Longest Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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 |
Lists (by program, study, and region) all sites and the number of subjects enrolled, completed, early terminated, as well as the percentage of subjects early terminated.
This report indicates the progress of subject retention, and the rate of subject retention.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site Team Member.Full Name
Study-Site Team Member.Role
Study-Site.Study-Site Status
Table A-34 describes the columns in the Patient Retention Table report:
Table A-34 Patient Retention Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site. |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site Team Member |
Full Name |
Study-Site Team Member.Full Name |
|
Study-Site Team Member |
Role |
Study-Site Team Member.Role |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
NA |
# Subjects Enrolled |
Study-site Metrics.# Subjects Enrolled |
|
NA |
# Subjects who have completed Study |
Study-site Metrics.# Subjects who have completed Study |
|
NA |
# Early Terminations |
Study-site Metrics.# Early Terminations |
|
NA |
% Subjects Early Terminated for Study-site |
Study-site Metrics.% Subjects Early Terminated for Study-site |
Displays (by study) the number of planned sites, the number of sites that have screened 1 or more subjects, and the number of sites that have enrolled 1 or more subjects. Bottom 10 based on # Enrolled.
This report indicates the progress of site activation. It also indicates the number of sites that are enrolling and screening.
Table A-35 describes the columns in the Planned Sites vs. Sites Screening & Enrolling Chart (Bottom 10) report:
Table A-35 Planned Sites vs. Sites Screening & Enrolling Chart (Bottom 10) Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study |
Study |
Study.Study |
|
Study |
Study Status |
Study.Study Status |
|
NA |
# Study-Sites Planned for Study |
Study Metrics.# Study-Sites Planned for Study |
|
NA |
# Sites with 1 or More Subjects Screened |
Study-site Metrics.# Sites with 1 or More Subjects Screened |
|
NA |
# Study-Sites with 1 or more Subjects Enrolled |
Study-site Metrics.# Study-Sites with 1 or more Subjects Enrolled |
Displays (by study) the number of planned sites, the number of sites that have screened 1 or more subjects, and the number of sites that have enrolled 1 or more subjects. Top 10 based on # Enrolled.
This report indicates the progress of site activation. It also indicates the number of sites that are enrolling and screening.
Table A-36 describes the columns in the Planned Sites vs. Sites Screening & Enrolling Chart (Top 10) report:
Table A-36 Planned Sites vs. Sites Screening & Enrolling Chart (Top 10) Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study |
Study |
Study.Study |
|
Study |
Study Status |
Study.Study Status |
|
NA |
# Study-Sites Planned for Study |
Study Metrics.# Study-Sites Planned for Study |
|
NA |
# Sites with 1 or More Subjects Screened |
Study-site Metrics.# Sites with 1 or More Subjects Screened |
|
NA |
# Study-Sites with 1 or more Subjects Enrolled |
Study-site Metrics.# Study-Sites with 1 or more Subjects Enrolled |
Displays (by study) the number of subjects randomized. Each bar in the report is stacked by region.
This report indicates how many subjects are in which status. It also indicates the number of subjects that have been screened, enrolled, and randomized.
This report also displays the progress of each region towards enrollment.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID #
Study-Site.Site Name
Study-Site.Study-Site Status
Lists all sites and the number of subjects planned and number of subjects randomized.
This report indicates how many subjects are in which status. It also indicates the number of subjects that have been screened, enrolled and randomized.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site Team Member.Full Name
Study-Site Team Member.Role
Study-Site.Study-Site Status
Table A-38 describes the columns in the Randomization Overview By Site Table report:
Table A-38 Randomization Overview By Site Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site Team Member |
Full Name |
Study-Site Team Member.Full Name |
|
Study-Site Team Member |
Role |
Study-Site Team Member.Role |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
NA |
# Subjects Planned for Study-Site |
Study-site Metrics.# Subjects Planned for Study-Site |
|
NA |
# Randomized |
Study-site Metrics.# Randomized |
Displays (by site) the number of subjects who failed screening.
This report indicates which screen failure reasons account for the most screen failures.
Table A-39 describes the columns in the Screen Failure Reason by Site Chart (Top 10 # Screen Failures) report:
Table A-39 Screen Failure Reason by Site Chart (Top 10 # Screen Failures) Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
Subject Status |
COUNT("- Subject Metrics"."Subject Status") |
|
Subject |
Screen Failure Reason |
Subject.Screen Failure Reason |
|
Study-Site |
Study, Site, & Investigator |
Study-Site.Study, Site, & Investigator |
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.
Lists (by program, study, and region) all sites that have screen failures and the number of screen failures that fall into a given screen failure reason.
This report indicates which screen failure reasons account for the most screen failures.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site.Study-Site Status
Subject.Screen Failure Reason
Table A-41 describes the columns in the Screen Failure Reason Counts by Site Table report:
Table A-41 Screen Failure Reason Counts by Site Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
Subject |
Screen Failure Reason |
Subject.Screen Failure Reason |
|
NA |
Subject Status |
Subject Metrics.Subject Status |
|
NA |
Subject Status |
COUNT("- Subject Metrics"."Subject Status") |
Displays (by study) the number of subjects screened. Each bar in the report is stacked by region.
This report indicates how many subjects are in which status. It also indicates the number of subjects that have been screened, enrolled and randomized, and the progress of each region towards enrollment.
CO - Site and Recruitment Overview dashboard, Screening Overview page
CO - Study and Region Overview dashboard, Enrollment 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.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site Team Member.Full Name
Study-Site Team Member.Role
Study-Site.Study-Site Status
You can navigate to this report from the following reports:
Table A-43 describes the columns in the Site Detail Table report:
Table A-43 Site Detail Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site Team Member |
Full Name |
Study-Site Team Member.Full Name |
|
Study-Site Team Member |
Role |
Study-Site Team Member.Role |
|
Study-Site |
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 |
Displays (by region) the number of sites in each status.
This report indicates the progress of each region towards enrollment. It also indicates the progress of site selection and the number of sites that are ready to enroll.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Study-Site Status
Study-Site.Principal Investigator
Table A-44 describes the columns in the Site Status by Region Chart report:
Table A-44 Site Status by Region Chart
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Program |
Study-Site.Program |
|
Product |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
NA |
# Study-Sites |
Study Metrics.# Study-Sites |
Displays (by month) the cumulative number of subjects completed compared to the number of subjects planned to be enrolled.
This report indicates how many subjects are being retained, and not early terminated from the study, compared to the number of subjects planned to be enrolled.
Table A-45 describes the columns in the Subject Retention Over Time report:
Table A-45 Subject Retention Over Time Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
100% Planned Site Enrollment |
Max(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))) |
|
NA |
90% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.9 ) |
|
NA |
75% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.75 ) |
|
NA |
50% Planned Site Enrollment |
MAX(sum((CASE WHEN"- Study-site Metrics"."# Subjects Planned for Study-Site">0 THEN "- Study-site Metrics"."# Subjects Planned for Study-Site" ELSE 0 END))*.5 ) |
|
NA |
# Subjects Enrolled |
RSUM("- Study-site Metrics"."# Subjects who have completed Study") |
|
NA |
Year and Month |
Date."Year and Month" |
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.
Study-Site.Study, Site, & Investigator
Study-Site.Study-Site Status
Subject.Screening #
Subject.Screen Failure Reason
Subject.Subject Comments
Subject Metrics.Subject Status
Subject Metrics.Status Comment
Table A-46 describes the columns in the Subjects who Failed Screening Table report:
Table A-46 Subjects who Failed Screening Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Study-Site |
Study, Site, & Investigator |
Study-Site.Study, Site, & 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.
Study-Site.Study, Site, & Investigator
Subject.Enrollment Id
Subject.Withdrawn Reason
Subject.Subject Comments
Table A-47 describes the columns in the Subjects Withdrawn List Table report:
Table A-47 Subjects Withdrawn List Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Product |
Product Name |
Product.Product Name |
|
Region |
Region Status |
Region.Region Status |
|
Study |
Study Status |
Study.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 worklog to take to a site visit to drive activity.
Table A-48 describes the columns in the Summary of Subjects Awaiting EDC Processing report:
Table A-48 Summary of Subjects Awaiting EDC Processing Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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
Table A-49 describes the columns in the Summary of Subjects Awaiting Paper Processing report:
Table A-49 Summary of Subjects Awaiting Paper Processing Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
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 |
Displays (by withdrawn reason) the number of subjects who terminated early.
This report indicates which withdrawn reasons account for the most early terminations.
CO - Subject Retention dashboard, Subject Retention Overview page
CO - Subject Retention dashboard, Early Termination Overview page
Lists (by program, study, and region) all sites that have early terminations and the number of early terminations that fall into a given withdrawn reason.
This report indicates which withdrawn reasons account for the most early terminations.
Study-Site.Program
Product.Product Name
Study-Site.Study
Study.Study Status
Study-Site.Study Region
Region.Region Status
Study-Site.Study-Site ID#
Study-Site.Site Name
Study-Site.Principal Investigator
Study-Site.Study-Site Status
Subject.Withdrawn Reason
Table A-51 describes the columns in the Withdrawn Reason Counts by Site Table report:
Table A-51 Withdrawn Reason Counts by Site Table Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
Program |
Study-Site.Program |
|
Subject |
Product Name |
Product.Product Name |
|
Study-Site |
Study |
Study-Site.Study |
|
Study |
Study Status |
Study.Study Status |
|
Study-Site |
Study Region |
Study-Site.Study Region |
|
Region |
Region Status |
Region.Region Status |
|
Study-Site |
Study-Site ID# |
Study-Site.Study-Site ID# |
|
Study-Site |
Site Name |
Study-Site.Site Name |
|
Study-Site |
Principal Investigator |
Study-Site.Principal Investigator |
|
Study-Site |
Study-Site Status |
Study-Site.Study-Site Status |
|
Subject |
Withdrawn Reason |
Subject.Withdrawn Reason |
|
NA |
Subject Status |
COUNT("- Subject Metrics"."Subject Status") |
Displays (by site) the number of early terminations.
This report indicates which withdrawn reasons account for the most early terminations.
Table A-52 describes the columns in the Withdrawn Reason Overview Chart (Top 10 # Early Terms) report:
Table A-52 Withdrawn Reason Overview Chart (Top 10 # Early Terms) Column Descriptions
| Table Heading | Column Heading | Measure |
|---|---|---|
|
NA |
Subject Status |
Subject Metrics.Subject Status |
|
NA |
# Early Terminations |
Study-site Metrics.# Early Terminations |
|
Subject |
Withdrawn Reason |
Subject.Withdrawn Reason |
|
Study-Site |
Study, Site, & Investigator |
Study-Site.Study, Site, & Investigator |
|
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