Enhancements to screening and enrollment management

Before you work with these feature

The following permissions are required to work with this feature:

Only users assigned the Edit Form Data for Subjects permission can screen subjects and edit screening and enrollment dates.
Site and sponsor users assigned the new Undo Enrolled permission have the ability to revert a subject's enrollment status. This permission is also added to the Site (Template) role.

Note:
If your study does not include any subjects with a status of Enrolled, this permission has no impact.
Sponsor users assigned the Edit Study Settings permission can configure the study, site, and country enrollment limits in the Study Settings page. This permission must be assigned along with the View Study Settings permission.

More information can be found in the Add Users Guide after the assessment environment upgrade completes.

Update system assigned dates for Screening and Enrollment

When it comes to modifying screening and enrollment dates, here's what's new for you, as a site user:

Once you select Screen for a subject, you are prompted to enter the Screening Event Date.
- By default, the current date is selected.
- If needed, you can select a different Screening Event Date in the Confirmation dialog.
- If a subject number hasn't been assigned, you are required to edit the screening date from the Manage menu on the Subject List page for the subject.
On the Subject List page, the Edit Screened option is available in the Manage menu once the subject has been screened , as long as the subject is not locked or frozen.
After you enroll a subject, you can access Edit Enrollment from the Manage menu on the Subject List page. You can edit the enrollment date even if the subject has moved to a different status, as long as the subject isn’t locked or frozen.
Both the Edit Screened and Edit Enrolled dialogs allow you to update the date of screening or enrollment and provide a Reason for Change.
When you modify the screening date, you can’t set it earlier than the screening visit date or later than the visit date of the next scheduled visit after the initial screening visit.
- The screening date for rescreen visits must be set to after or on the previous screening and screen fail dates and cannot be set after the next scheduled visit.
- The screening visit cannot be after a subsequent screening or screen fail date.
Note:

The restrictions apply only to changing the screening date; they do not apply to visit dates.

The order of the screening and screen fail events is based on the order of the visits in which they occurred.
You can update the screening date upon successful screening, as you can for manual screen fail, withdrawal, and completion.
Updates to screening or enrollment dates are reflected in the Subject History with a label of Screen Update or Enroll Update.

More information and step-by-step instructions can be found in the Site User Guide after the assessment environment upgrade completes.

Undo a subject's enrollment

In studies that do not include randomization, subjects are automatically transitioned from a status of Screened to Enrolled when they complete the visit following Screening type visit. Now, even after a subject is enrolled, sponsor users can revert the subject's status. When it comes to undoing a subject's enrollment status, here's what's new for you:

Subjects that have been rolled over into the study and were never at a status of Screened cannot have their enrollment undone.
On the Subjects List page, the Undo Enrolled option is now available in the Manage menu, as long as the subject held a status of Screened at some point. Once selected, the subject returns to a status of Screened and allows the subject to be screen failed.
Once you select Undo Enrolled, you must enter a Reason for Change in the Undo Enrolled dialog. You can either select Subject Enrolled in Error or Other.

Note:
These codelist options can be modified.
If a scheduled visit moves to a status of Complete after Undo Enrolled has been performed and the subject is marked as Screened, the subject is reverted to a status of Enrolled.
Once a subject's enrollment has been undone , a new event of Reinstated is created.
A subject's enrollment cannot be undone if the subject is locked or frozen. However, a subject's enrollment can be undone if some data is locked or frozen.
There is no impact to verification or signature status for questions, forms, or visits if Undo Enrolled is performed.
Updates on the subject's enrollment, after undoing it, are reflected in the Subject History.
If you perform Undo Enrolled in error and there are no additional visits to complete, you can clear a question on any scheduled visit and re-enter the data to return its status to Complete. This results in the subject being re-enrolled.

More information and step-by-step instructions can be found in the Site User Guide after the assessment environment upgrade.

Validate enrollment limits before subject screening

For studies where subject numbers are assigned after screening, enrollment limits are now validated before allowing site users to screen a candidate. Enrollment limits can be set by sponsor users at the study, site, and country levels, as well as for cohorts and custom enrollment groups. If the limit is reached, enrollment is closed at that level.

Note:

This enhancement only considers enrollment limits at the study, site, and country levels. Other limits are still validated but upon data submission only.

With this enhancement, the enrollment limits are verified by the system in real time, blocking site users from screening candidates when enrollment limits have been reached. In these cases, the Screen Candidate button is disabled and a tooltip informs users about the closed enrollment. This avoids unnecessary data entry and site effort invested during the screening process of a subject that won't proceed.

However, if the screening of a candidate is allowed, Clinical One Cloud Service still validates enrollment limits upon data submission. In case there are any other enrollment limits reached, or if enrollment becomes closed or limits reached during data collection:

The system prevents screening showing an error message.
Subject number is not assigned.
Data is not saved nor propagated.

More information can be found in the Sponsor and CRO User Guide and the Site User Guide after the assessment environment upgrade completes.

Impact on reports, extracts, archives, or datasets

The following table describes this feature's impact to reports and datasets:

Report, extract, archive, or dataset	Type of change	Description
Subject Events report	Modified column data	Be aware that updates to the screening and enrollment dates create a related Subject Event that is included in the Subject Events Report and is supplied to downstream systems. The new Reinstated (Undo Enrolled) event is introduced to the Subject Events report.
Study Enrollment report	Modified column data	The number of enrolled subjects is reduced when Undo Enrolled is performed. Additionally, there is no impact on the number of screened subjects.
Subjects dataset	New and modified column data	The new ENROLLMENT_DATE column displays in the Subjects Dataset with details on the updated enrollment date. Additional details on the updated enrollment date display in the REASON and COMMENT columns, as well. Updates to the screening date display in the existing columns when applicable: SCREENING_DATE REASON COMMENT
ODM Clinical Data extracts	New attributes	The following new attributes are added as Clinical One extensions: ScreenedDate EnrolledDate Both attributes are added at the subject level when the values are not null.

More information can be found in the Reporting Guide, the Analytics User Guide, and the REST API for Clinical One Cloud Service documentation after the assessment environment upgrade.

Impact on integrations

For more information on downstream services updates, see Release impact on other applications.

Already working in a live study?

Once the production upgrade completes, users with the appropriate permissions can manage screening and enrollment dates, as well as undo a subject's enrollment.

The change in behavior of the enrollment limits validation also becomes effective as soon as the production upgrade completes.