Enhancements to Oracle CRF Submit archives and reports
Form & Visit level Signatures and Affidavits (from code lists) are now supported
Starting with 23.1, signatures can now be configured at the form and visit level. Subject PDFs include the signatures and indicate the type of signature applied, Form, Visit, or Subject. The affidavit text is displayed according to the signature configuration, using the code list value as of the signature date.
Previously, subject PDFs included the signature history at the form level when all items on a form or the subject casebook were signed. The associated affidavit text was displayed using the code list value as of the signature date.
You can find more information about signing at the visit and form level in the Site User Guide, and details about signature configuration can be found in the Sponsor and CRO User Guide after the Release Assessment Environment upgrade.
The As of Date in the Request Settings PDF now displays in a users time zone
In the request settings PDF, the As of Date now displays the date/time based on the time zone settings of the user who generates the request. Previously, the Request Settings PDF displayed GMT by default.
Electronic Trial Master File (eTMF) transfers are now supported
Oracle CRF Submit output files for Archival PDF (sponsor and site), and Custom PDF archive requests can now be delivered to the Oracle sFTP server. These files can be programmatically transferred to your eTMF storage system or downloaded manually in the Oracle Clinical One Platform user interface.
You can find additional information in the Reporting Guide after the Release Assessment Environment upgrade.