Enhancements to Oracle CRF Submit archives and reports

Subject PDFs now include Visit Date query details

Now, custom and manual queries can be created to check that the date entered for the Visit Date fits within the specified visit window defined for a study.

Visit Date query details are included in the subject PDF eCRF Audit Trail History section of Submission, Archival, and Custom archive requests.

Replacing the subject number with the randomization number is supported in subject PDFs and reports

Now, users can configure studies to replace the subject number with the randomization number after randomization. When configured, the randomization number is visible anywhere the subject number was displayed in the study.

The Subject No: field in the subject PDF header and the Subject ID column in the Download Log report display the original subject number assigned after screening or the updated subject number assigned after randomization, depending on when the PDF or the report is generated.

Note:

The Download Log contains a history of all downloads and may include both values if subject PDFs were generated before and after randomization.

More information about this enhancement can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Form associations for two-section forms are now supported in subject PDFs

In a previous release, we introduced the ability to link between the sections of a two-section form (flat and repeating) and other form types.

Such associations, the removal of these associations, and all audit history details are now included in the subject PDFs.

More information about Linking forms can be found in the Site User Guide.

Email and in-application notifications are now available

Email and in-application notifications can be configured to notify sponsor and site users about the status of PDF and report requests and to inform sponsor users about site-level PDF request, download, and confirmation activities.

This feature, available in Testing and Production modes only, is turned off by default. To enable the feature and manage notifications, the Manage Archives Settings permission must be assigned to access the new Archives Settings tab available under Study Settings.

Table 4-2 Notification name, details, and required permissions

Notification name	Notification details	Required permissions to receive the notification
Request available for download	Site and sponsor users receive this notification when a request has been completed successfully and is available for download.	Run Archival PDFs for your site(s) (Site) Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request failure	Site and sponsor users receive this notification when a request has failed to complete successfully.	Run Archival PDFs for your site(s) (Site) Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request submitted by site user	Sponsor users receive this notification when a site user has generated a new request.	Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request shared with site downloaded	Sponsor users receive this notification when a request shared with a site has been downloaded by that site.	Run and download Site Confirmation and Download Log audit reports
Request confirmed by site	Sponsor users receive this notification when a request shared with a site has been confirmed by the site after they have downloaded and reviewed its contents.	Run and download Site Confirmation and Download Log audit reports
Storage limit has exceeded	Sponsor users receive this notification when the storage limit has reached 75% capacity.	N/A: Sponsor users with access to Oracle CRF Submit receive this notification.

More information about this enhancement can be found in the Reporting Guide after the Release Assessment Environment (RAE) upgrade.