New Site Confirmation report for the Archival PDF

Sponsor users can now enable site confirmation for site users to confirm that they have downloaded and reviewed the archives generated in the system.

What are the benefits?

The Site Confirmation report lets sponsor users understand how many of the archives are downloaded and reviewed by site users in a study. By getting an overview and exact count of site confirmations, they can also notify site users, outside of Oracle Clinical One Platform, in case they discover that some archives have not been downloaded and reviewed.

Details for user administrators

Nothing has changed in your workflow. However, you do need to know that only a sponsor user who is assigned the Run and download all PDF request types and Audit reports. Enable Share with Sites and Site Confirmation permission can generate the Site Confirmation report.

Details for study team members

On the Reports & Archives tab, under Archives, you now see the new Site Confirmation report. You can generate that report in either a CSV or PDF format, as well as give it a different name.

Additionally, for an Archival PDF, you can now configure the Confirm Site Downloads setting to either Yes or No.

Details for site users

From now on, upon downloading an Oracle CRF Submit archive, you may have to confirm that you have downloaded and reviewed the archives.

Already working in a live study?

As soon as the upgrade for this release is done, with the appropriate permission, you can start configuring the Confirm Site Downloads setting for the Archival PDF and generating the Site Confirmation report.