Manage subject event related data and visits better

Sponsor and site users can view the Screen Failure, Study Completion, and Withdrawal visits until all data is removed or the related statuses are reverted, allowing site staff to access undone visits during this time. Site users can also edit a subject's study completion or withdrawal date, as well as the reason specified for a subject's withdrawal.

Note:

With the release of this enhancement, issue 31272901 is now fixed, as well. Previously, this was reported as a Known Issue in our documentation. When a site user decided to undo a subject's withdrawal, their associated Withdrawal visit remained displayed, and the subject remained signed when the visit data should have become unsigned. Additionally, the system counted the Withdrawal visit as a signed visit. Now, when a site user undoes a subject's withdrawal event, upon clearing the data for their Withdrawal visit, the subject and visits status align since the visit is removed from the User Interface (UI).

Before you work with this feature

As a user administrator, there are some new permissions that you need to be aware of. These are now included by default in the CRA, Data Manager, and Site User global study role templates. The following new permissions are introduced:

New permission	Description
Receive the Subject Undo Completion Notification	You can assign this new permission to a sponsor or site user that needs to be notified when a subject's Completion visit is undone.
Receive the Subject Undo Withdrawal Notification	You can assign this new permission to a sponsor or site user that needs to be notified when a subject's Withdrawal visit is undone.
Receive the Subject Undo Screen Failure Notification	You can assign this new permission to a sponsor or site user that needs to be notified when a subject's Screen Fail visit is undone.

For more information on these new permissions, see Notifications permissions in the Add Users Guide after the Release Assessment Environment (RAE) upgrade.

Details for sponsor users

Whether you're a study designer, a clinical supply manager, or a site administrator, here's what you need to know about this enhancement:

If your study has a predictive resupply strategy set up, the algorithm determines the appropriate amount of kits to be sent out to sites based on the subjects' current state (whether Screened, Enrolled, Randomized, Active, etc.).
With the appropriate permissions, you or any other user can now receive any of the three new notifications: Subject Undo Completion, Subject Undo Withdrawal, and Subject Undo Screen Failure.

If you're interested in learning more about the changes in site users' workflow, check the Details for site users section below.

Details for site users

Here's what's new in your workflow for managing subjects, their data, and their status in the context of screen failure, study completion, and withdrawal:

Note:

Editing details for a subject's screen failure event (such as the date and reason for the screen failure) is existing functionality.

Upon choosing to undo a subject's event (whether it's manually undoing a subject's screen failure, study completion, or withdrawal), a specific dialog is displayed. The Undo dialog requests you to specify a reason for this change and it also notifies you that undoing this subject's event preserves all data from the associated visit. The visit remains visible and accessible until you clear all data, including hidden data.
Once you undo a subject's, screen failure, completion of the study, or their withdrawal, if there's an associated Screen Failure, Study Completion, or Withdrawal visit, that visit is displayed on the Previous Visits column. This also applies to a subject that you successfully re-screen.
Once all data is cleared from the visit and all associated queries are closed, the visit is no longer displayed on the Previous Visits column. The visit will only remain visible if there is data present in the associated visit.
When a subject's screen failure, study completion, or withdrawal event is undone, the status of that subject is updated again to New, Screen Failed, Active, Screened, or Enrolled, depending on the situation.
You can also edit a subject's study completion and withdrawal details, such as the date of the event (for both Study Completion and Withdrawal), or the reason for that subject's event (only available for Screen Failure and Withdrawal). When you select a subject who's already withdrawn or completed, the Manage Subjects drop-down displays two new options: Edit Withdrawal and Edit Completion, respectively.
If a subject's Screen Failure, Study Completion, or Withdrawal visit contains locked or frozen data, you cannot undo a subject's event. When you attempt to undo a subject whose Screen Failure, Study Completion, or Withdrawal visit contains these types of data, an Error dialog is displayed informing you of this issue.
If a subject's overall status is Locked, the option to undo any of their events isn't displayed on the Manage Subjects drop-down at all.
Before you undo a subject's event, if there are any open or answered queries included in forms for the associated visit (Screen Failure, Study Completion, Withdrawal visit), you should reach out to a sponsor user to ensure that all open or answered queries are manually or automatically closed.

Impact on integrations

For more information on the impact on integrations, see Support for undoing subject events.

Impact on custom JavaScript rules

If you're a rule designer, publisher, or tester, here's what you need to know about this enhancement:

Whether it's specified or edited by a site user, or defaulted by the application, the dates of a subject's withdrawal, completion, and screen failure (as well as the date of the undoing) are returned to the Subject Object attributes for the respective dates. The subject object used in custom rules throughout your study reflects the updated data.
If clearing a question triggers a calculation rule to populate a target field in a visit that is being cleared, that visit will not be hidden until the calculation is cleared by the rule.

For more information

Impact on reports

For more information on the modified reports, see the corresponding reporting topics in the Reporting Guide and the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.

Consider the following notes for how data is reported in certain reports for this enhancement:

In the Subject dataset, only the reason specified for a subject's screen failure or withdrawal events is displayed. In Oracle Clinical One Platform, you are not required to specify a reason for the subject's study completion, therefore there is no reason to display for this event for the REASON data element.
For the Subject dataset, the Subject Events report, and the Subject Data for CTMS report, while you can see the reason for change that is specified anytime an update occurs for a subject's screen failure, study completion, or withdrawal event, you cannot view any updates to the event's specific reason. For example, if a subject's Reason for Screen Fail is updated in Oracle Clinical One Platform, this update is not specified in these reports. This capability will be introduced in a new future release. For more information on release impact to other applications, see Patch set impact on other applications.

Report	Type of change	Description
Subject Events report	Modified column description and new filter	The following changes can be found in this report: New options are available for the Event Type filter: Screen Fail Update, Completion Update, Withdrawal Update. When a site user edits a subject's date for their withdrawal, screen failure, or study completion, the Event Type column displays this as a separate event (Completion Update, Withdrawal Update, or Screen Fail Update). The Visit/ Event Date column, displays the updated date of a subject's withdrawal, screen failure, or study completion event when edited by a site user.
ODM-XML extract	New field	The following Clinical One extension fields are included at the subject level: co: WithdrawalDate: This field will only be visible for subject status transactions with a status of Withdrawn, when the date entered does not match the current system date (the user-entered date). It doesn't display for other subject status transactions. co: CompletionDate: This field will only be visible for subject status transactions with a status of Complete, when the date entered does not match the current system date (the user-entered date). It doesn't display for other subject status transactions. Additionally, when a site user edits a subject's withdrawal and completion dates, these new dates are reflected in the Clinical data extract, including the updated date and reason for change.
Subject dataset	Modified data element descriptions	When a subject's withdrawal, screen failure, or study completion details are updated, the following data points are now included in the EVENT_TYPE data element: Screen_Fail_Update WithdrawalUpdate CompletionUpdate The reason specified for the overall update to a subject's event details is included in the REASON data element. The date associated with a subject's Screen Failure, Study Completion, and Withdrawal event (along with undoing these events) is displayed in the STATE_DATE data element. The Withdrawal date is also displayed for the STATE_DATE when a subject's withdrawal occurs due to code break.

Already working in a live study?

If you're already working in a live study, consider the following notes that apply once this new feature is released:

If a Withdrawal, Screen Fail, or Study Completion visit was previously hidden, while having any data, open, answered, or candidate queries associated with it, the visit will resurface in your study after the upgrade is complete, and it can only be hidden if you clear its data.
Any statuses related to Source Data Verification, data freezing, or signing are not impacted by any resurfacing Screen Failure, Study Completion, or Withdrawal visits.
Queries are hidden if the associated visit (Screen Failure, Study Completion, or Withdrawal visit) is in a state of New when this feature first becomes available in your study. To view the queries, go to the Queries sidebar or access the Query Management page.
If a locked subject's Screen Fail, Study Completion, or Withdrawal hidden visit resurfaces after this upgrade, a sponsor user must first unlock the subject before they or another site user can clear that visit's data and hide it again. The resurfaced visit's status is not displayed as Locked.

For more detailed information on this enhancement, see the following user guides after the Release Assessment Environment (RAE) upgrade:

Site User Guide
Sponsor and CRO User Guide
Notifications and Permissions Guide

Parent topic: Data collection