Site Confirmation report (for site and sponsor users)

Sponsor and site users can generate this report (CSV or PDF) to view an audit history of confirmation actions performed by site users.

Sponsor users can share the Archival PDF (for sponsor users), Custom PDF, and the Kit Chain of Custody (Blinded) report with site users and request that they confirm they have downloaded and reviewed the content.

This report includes the confirmation date and time, the user name of the person who performs the action, and the status (Confirmed and Not Confirmed) of each archive shared with sites where confirmation is requested.
  • For sponsor users, the report includes confirmation details for all sites in a study, but site users can only see details for their assigned sites.
  • Requests shared with sites and later deleted by the sponsor appear in the report with the status of Not Confirmed.
  • The pluggable database (PDB) package, provided to the customer during the study decommission process, includes a final version of this report. For more information, see Decommission a production study.

Modes

Available only in Testing and Production mode. To get started, Access the Reports & Archives page.

Required permissions

Users assigned to one of the following permissions can generate this report.
  • Sponsor users: Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
  • Site users: Confirm download of Archival PDFs and content (Site)