Clinical Trials Operational Analytics (CTOA) provides an overview of operational data such as Enrollment, Query and Audit metrics, Adverse Event rates, and Protocol Deviations.
CTOA can be grouped by compound, therapeutic area, or program. If the CTOA app is configured to be grouped at the URL level, the name will reflect the grouped app.
CTOA, like all Analytics apps, has several common features such as filtering, selection tools, bookmarks, etc. For details on all Analytics functionality, please refer to the Analytics section or the Analytics courses in the Learning Portal.
In this article, you will find information on all the available out-of-the-box CTOA sheets. Use the Table of Contents at the right to navigate to the sheets of interest.
Important: The list of sheets does not include custom sheets specific to your team.
CTOA Home Page
The Home Page displays key summary information and metrics across all studies.
- By default, the stacked bar chart located in the top left corner presents the Current Subject Status, displaying where subjects are presently in the trial process.
- To explore historical data, click on Historical Subject Status. This chart displays the progression of subjects from status to status, allowing you to visually compare segments and observe how they evolve as the trial progresses.
Tip: Any applied filters (shown in the Selections toolbar) will remain when you move to another sheet. Remove a filter by clicking the 'x' next to the filter in the Selections toolbar.
Enrollment Summary
Use the Enrollment Summary sheet to view enrollment metrics and information by Study, Country, Site, Status, and Group Assignment.
- In the Enrollment Summary chart, click on the x-axis drop-down arrow to select from Site Number (default), Country, or Study.
- In the Enrollment Details chart, click on the y-axis drop-down arrow to select from Site Number (default), Study, or Country.
Recruitment and Retention
Use the Recruitment and Retention sheet to monitor the subject recruitment and retention metrics for sites based on thresholds you set for key metrics to determine if a site is enrolling at an acceptable rate. Based on the entered threshold rates, the report shows values which are On Target, Under Target, or Action Required.
Planned enrollment numbers must be provided during configuration for the sheet to reflect accurate study details.
If multiple studies are available, select one Study.
- Enter threshold rates for:
- Planned Enrollment on Target % (>=) and Action Required % (<=)
- Screen Failed on Target % (<=) and Action Required % (>=)
- Consented on Target % (>=) and Action Required % (<=)
- Discontinued on Target % (<=) and Action Required % (>=)
Enrollment Trend
Use the Enrollment Trend sheet to view actual, planned, and cumulative enrollment trends in various forms. You can compare the actual enrollment with the enrollment forecast at a site broken out by year and month.
Planned enrollment numbers must be provided during configuration for the sheet to reflect accurate study details.
If multiple studies are available, select one Study.
- Use the tabs across the top to see Cumulative Actual Enrollment (default), Cumulative Enrollment, or Cumulative Screen Failure.
- In the Planned vs Actual Totals by Study/Site/Country chart, click on the x-axis drop-down arrow to select from Study (default), Site, or Country.
- In the Actual Study Enrollment vs Actual Site Enrollment chart, to see a site compared to the entire study, select only one site.
Subject Early Discontinuation
Use the Subject Early Discontinuation sheet to get detailed information for subjects who withdrew, dropped out, or discontinued from the study (or studies) for various reasons.
- In the Early Termination Subjects by Site / Reason chart, use the buttons in the top right corner to view by Site (default) or Reason.
- Click on the y-axis drop-down arrow to select from # of Subjects (default) or % of Subjects.
Query Metrics
Use the Query Metrics sheet to find information regarding query metrics.
If multiple studies are available, select one Study.
- By default, 20% is the default Open Query Threshold rate. Update the value if you choose. Sites that exceed the defined threshold are highlighted in yellow.
Queries Duration
Use the Queries Duration sheet to view the duration of queries in the opened status, the average number of days it took for the opened queries to be answered, and the average number of days it took for the answered queries to be closed, along with other relevant metrics.
- Enter an unacceptable number of Average Days Outstanding (>=) in the threshold field to focus the data on the sites with average days outstanding greater than or equal to the number entered.
- In all charts, click on the y-axis drop-down arrow to select from # of Queries (default) or % of Queries.
- In all but the first chart, click on the x-axis drop-down arrow to display the % of Queries instead of the default value.
Query Details
Use the Queries Details sheet for detailed information on all queries by site, folder, form, or data field.
- In the Queries by Sender / Site / Recipient chart, click on the y-axis drop-down arrows to select from Query Sender (default) or Query Recipient, and Site (default) or Query Recipient.
- In the Queries by Sender-Recipient and Site (default) / Folder / Form / Data Field chart, use the 4-button group above the chart to toggle between the options.
- Click the drop-down at the top left of the chart to view All (default) data, or for the Top 10 sites only.
Queries by Open Date
Use the Queries by Open Date sheet to view the cumulative number of queries opened over time by Site and User / Sender-Recipient. Additionally, view Query Details by Site and Subject.
Click on a year, month, week, and then day in one of the top two charts to drill down to when the queries were opened.
Query Response
Use the Query Response sheet to view the details on query response time.
- For the Average Response in Days by Site Over Time chart, enter the graph's desired timeframe in months, 12 (months) is entered by default.
- The chart will go from the current day back to the number of months entered.
- In the Queries by Open to Answered Duration chart, click on the y-axis drop-down arrows to select from Open to Answered Duration (default), Country, or Study, and Site (default), Country, or Study.
Protocol Deviations - Overview
Use the Protocol Deviations - Overview sheet to find details related to subjects who had protocol deviations.
- Click on the Major (default) or Minor button in the upper left and enter a value into the threshold field to filter outliers based on the threshold value.
- In the Protocol Deviations by Site chart, click on the x-axis drop-down arrow to select from Site of Deviation (default) or Current Site.
- In the Protocol Deviations Over Time chart, click on the y-axis drop-down arrow to select from # of PDs (default) or # of PDs/Subject.
- Click on the x-axis drop-down arrow to select from Date (default) or Visit. If a protocol deviation happened unrelated to a visit, the visit will be shown as 'missing.'
- In the Class, Form, Field and Protocol Deviations by Site chart, click on the y-axis drop-down arrows to select from Site of Deviation (default), Current Site, Form, Field, or Protocol Deviation, and Class (default), Current Site, Form, Field, or Protocol Deviation.
Protocol Deviation Details
Use the Protocol Deviation Details sheet to view details regarding subjects with protocol deviations, as well as the number of eligible vs ineligible subjects who had protocol deviations. Also, identify the site of deviation details for subject transfers.
- In the Eligible vs. Ineligible Subjects (%) with PDs chart, click on the y-axis down-down arrows to select from Eligibility (default) or Current Site, and Site of Deviation (default) or Current Site.
- In the PD Subjects chart, click on the y-axis down-down arrows to select from Subject has PD? (default) or Current Site, and Site of Deviation (default) or Current Site.
AE and SAE Rate
Use the AE and SAE Rate sheet to view detailed information and metrics related to adverse events and serious adverse events (AEs and SAEs).
- Select the AEs (default) or SAEs button at the top left to view charts by AEs or SAEs.
- Enter a value in the # of AEs/Subject (>=) threshold field to quickly identify outliers.
- In the Subject / Event / Unresolved Ratio chart, select the Subject (default), Event, or Unresolved button.
Time to SDV and Details
Use the Time to SDV and Details sheet to view metrics related to Source Data Verification.
If multiple studies are available, select one Study.
Enter a threshold in the Average Days to SDV (>=) to quickly identify outliers.
Timeliness
Use the Timeliness sheet to view various metrics related to source data.
- In all charts, click on the x-axis drop-down arrow to select from Site (default), Form, Subject, Folder, Study or Field.
- In the Audits by Audit Date chart, there is another x-axis drop-down arrow to select from, Audit.TimeStamp (Year) -> Month (default), Subject, Study, Form, Folder, or Field.
Post SDV and Post Query Changes
Use the Post SDV and Post Query Changes sheet to view various metrics related to post source data verification and post query changes.
- In the Data Changes After SDV, Query Actions After SDV, and Number of Queries Resulting in a Data Change charts, click on the y-axis drop-down arrow to select from Site (default), Form, Subject, Folder, Study, or Field.
- In the Number of Queries Resulting in a Data Change chart, click on the x-axis drop-down arrow to select from # of Queries Resulting in a Data Change (default) or # of Subjects.
Data Changes
Use the Data Changes sheet to view data changes related to folders, forms, fields, and sites.
- For the Data Changes Over Time chart, enter the graph's desired timeframe in months, 12 (months) is entered by default.
- In the Studies or Sites with Changes chart, click on the x-axis drop-down arrow to select from Study (default) or Site.
- In the Forms or Folders with Changes chart, click on the x-axis drop-down arrow to select from Form (default) or Folder.
Audit Summary
Use the Audit Summary sheet to view metrics related to data changes by change reason and audits by user and action type.
- In the Data Changes by Change Reason chart, select a change reason (within the treemap), and / or a particular site (either within the treemap or the legend).
- In the Audits by Action Type chart, click on the y-axis drop-down arrows on to select from Site (default), Folder, Form, Field, Subject, or Study, and Action Type (default), Folder, Form, Field, Subject, or Study.
Application Information
Use the Application Information sheet to view application Information, such as what's new in CTOA for the version you are using, when the data was last refreshed broken out by domain, and a glossary of terms used in CTOA.
Download Sheet Descriptions
Click the links below to Download the PDF with full sheet descriptions.