Oracle CRF Submit archives and reports

The following details provide an overview of enhancements for Oracle CRF Submit archives and reports.

Time only and partial time questions are now supported in PDF output

The ability to capture time only and partial time using a Date/Time question was introduced in Oracle Clinical One Platform 22.3. Starting with this relase, the following enhancements are introduced:
  • Blank PDF output includes time only and partial time questions as active controls when they are included in your study design.
  • Subject PDF output includes time only and partial time questions and associated data when they are included in your study design.

Include Randomization and Trial Supply Management (RTSM) data in PDF output

A new setting called Include RTSM Data has been added to the advanced tab for Submission, Archival (both sponsor and site), and Custom PDF requests. Enable this setting to include randomization and dispensing information for subjects at your site in the PDF output.

You can find additional information in the Reporting Guide after the Release Assessment Environment upgrade.

Subject number changes are now supported in the user interface and output files

Previously, the updated subject number was displayed in the user interface for the Include In Report, Select Subjects, Subjects drop-down and subsequently in the output files even if the Select Date/Time entered was prior to the subject number change.

Now, the subject number displayed is based on the As of Date setting when creating requests.
  • If Now is selected, or if a date is entered that is after the update, the Subjects drop-down displays the updated subject number which is reflected in the output files.
  • If a date is entered for Select Date/Time that is prior to the subject number change, the user interface and output files include the original subject number.