Enhancements to Oracle CRF Submit archives and reports

We've increased the storage server space allocated for each customer

To accommodate the increasing usage of Oracle CRF Submit and to minimize the possibility of encountering issues when generating archives and history reports for large studies, we increased the storage server space allocated for each customer from 100 GB to 1000 GB.

Note:

Storage server space is allocated per customer and shared across all your studies.

PDF output supports Instructional Text questions

Study designers can add instructional text to any form to provide users with instructions to complete a form or the questions on it.

The text appears in Submission PDF, Archival PDF (sponsor and site), Blank Form PDF, and Custom PDF request output.

The PDF reflects the question's location on the form and the instructional text's font format (size, type, and color), as displayed in the user interface, but the PDF does not include a row number.
Email addresses and hyperlinks in the instructional text appear as plain text in the PDF.

For more information, see Instructional text.

A new pop-up reminds site users to confirm a request after download

After downloading an Archival PDF request, a Custom PDF request, or the Kit Chain of Custody (Blinded) report, a site confirmation required pop-up reminder is presented to site users when the sponsor who generated and shared the request requires confirmation.

The reminder appears for site users assigned to a study role that includes the permission Confirm download of Archival PDFs and content (Site).

After the Release Assessment Environment (RAE) upgrade, you can find additional information in Download an archive or report in the Reporting Guide.

The Site Confirmation report is available for site users

Sponsor users can share Archival PDF, Custom PDF, and the Kit Chain of Custody (Blinded) report with site users and require site confirmation after download; confirmation actions get tracked in the Site Confirmation report. For more information about the confirmation process, see Confirm an archive or report after download.

Site users assigned to a study role that includes the permission, Confirm download of Archival PDFs and content (Site), can generate the Site Confirmation report for associated sites.

After the Release Assessment Environment (RAE) upgrade, you can find additional information about this report (for site users) in the Site Confirmation report.

New lab forms now render as two-section forms in PDF output

The PDF layout for lab forms created before this release remains unchanged.

Archives generated after this release render newly created lab forms as two-section forms.

Note:

This change impacts the Submission PDF, Archival PDF (sponsor and site), and Custom PDF requests PDF output. There is no impact on Blank PDFs, as lab forms already display as two-section forms.

This change is to support an enhancement in this release that allows multiple instances of a lab form to be associated with the same visit. For more information about this enhancement, see Enhancements to local labs.