Archiving Studies

Learn the best practices for archiving studies in SiteVault.

Archiving is the process to initiate the long-term storage of the essential documents following the completion of a clinical research study.

Use the following checklist to ensure that your study is ready for archival:

  1. Study Tasks and Workflow:
  2. Study Documentation:
    • Check for any draft documents in the library that may need to be finalized in order to add to the eBinder.
    • Ensure that the eBinder contains all essential documents.
  3. Close Out Visit is Completed by Monitor:
    • Ensure that all essential documents have been monitored and have a Monitoring Status of Complete (No Issues). Note that Organization and Person Profile documents such as CVs or Medical Licenses will not have a Monitoring Status.
  4. Supersede Documents:
    • Once the monitor status is listed as Complete (No Issues), the document can be moved to the Superseded state to remain consistent with the study status.
    • This should not be completed for any Organization and Person Profile Documents.
    • If using Digital Delegation, the document will automatically update when the study team assignments are updated to inactive and the PI approves.
  5. Study Participants: If applicable, run reports to ensure that all participants are no longer active on the study.
  6. Partner Organizations: Set all partner organizations to Inactive.
  7. External Users: Set all study monitor assignments to Inactive. This should be done after the closeout visit as monitor assignments in the Inactive state will not be able to access documents to complete review.
  8. Products: Set all study products to Inactive.
  9. Study Team Assignments:
  10. Archive Study:
  11. Export Study Documentation: If applicable, export study documents per your site’s record-keeping SOPs.

Managing Study Participants
Overview of Documents
Knowledge Base
System Information
Site Tools