Enhancements to Oracle CRF Submit archives and reports

Study withdrawal and completion data for screen fail subjects is now included in subject PDFs

If the study setting, Screen Failed Subjects, is set to either Allow Withdrawal or Allow Completion, a site user can complete a withdrawal or completion visit for a screen-failed subject. The data captured in the visit is now included in the subject PDFs.

Note:

For more information about this setting, see Specify study, enrollment, and visit settings.

Sponsor users can now share the Kit Chain of Custody (Blinded) report with sites

Both sponsor and site users are required to archive the Kit Chain of Custody (Blinded) report, but site users are only sometimes granted access to this report. For more information about this report, see the Kit Chain of Custody (Blinded) report.

Sponsor users can now generate and share the Kit Chain of Custody (Blinded) report. The (new) site shareable report is under the Archives tab. The (existing) non-shareable report is under the Reports tab.

Note:

The permission, Run the Blinded Chain of Custody Report is required to generate the shareable report.

Although the settings for each report are different, the output is the same, as the output is generated from the same database tables and includes the following for each kit.

Creation of the kit
Assignment to a lot
Assignment to a depot
Shipped to a site
Dispensation to a subject
Destruction of a kit

Site users can only download this report. The report appears under the Download Archives side panel after being successfully generated by the sponsor and it only contains information for the site that you're assigned to.

Note:

Site user download and confirmation actions are tracked in the Download Log report and the Site Confirmation report.

PDF headers now include the Locked form status for non-repeating and repeating forms for locked subjects

As a part of the 22.3 release, we announced that the Locked status is included in the PDF header when forms are locked at the visit and form level.

For this release, the subject PDF header, specifically the Form Status row, now displays the Locked status for all forms in all visits when a subject is locked. The status appears in the output files generated for Submission, Archival, and Custom PDF requests.

Subject PDF behavior when a dynamic question is edited after data entry has already occurred

Suppose a site user incorrectly answers a determining (parent) question, such as a question that determines the treatment arm for a subject, and enters data in any dynamically generated element, such as a form question. The determining (parent) question can be edited by the user to remedy the situation. For more information about this feature, see Clearing dynamic questions and forms.

If the determining (parent) question is edited, the system asks the user to confirm if the data entered incorrectly on the dynamically generated elements should be cleared. If yes, the data except for data on frozen, locked, read-only, and hidden forms and questions is cleared.

If this occurs, subject PDFs capture information in the following ways.

The cleared questions display as empty cells in the subject PDF, and the Reason for Change, selected when the dynamic question was updated, is displayed in the question audit trail.
Form statuses, for example, Complete, Signed, and Verified, update accordingly when the dynamic question is edited. The statuses are accurately reflected in the subject PDF.
A signature is invalidated if clear data is applied to already signed data. If this happens, the subject PDF includes the signature invalidation audit for the form.
If the value cleared is a variable in a calculation, the calculation runs again upon saving. The calculated value is updated based on the logic of the calculation rule. The subject PDF reflects the correct data displayed in the question and the calculated value.
Open queries (auto and manual) are closed with the Reason for Change, Item Cleared, captured for each query.
Form disassociation details are captured in the subject PDF audit history if form associations are removed.
If a dynamic visit containing multiple forms is triggered, and the visit is canceled with no data entered into the dynamic visit, the Date of Visit form status is updated to Not Started, and the remaining added forms do not appear in the subject PDF.
If a dynamic visit containing multiple forms is triggered with data entered for the dynamic visit, and the entered date is cleared, the visit is canceled, and all forms have a status of Incomplete, with the exception of the Date of Visit form.