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: Run reports to ensure that all study tasks and workflows are complete.

  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.
    • Ensure that all essential documents have been monitored and have a Monitoring Status of Complete (No Issues).

  3. Study Participants: If applicable, run reports to ensure that all participants are no longer active on the study.

  4. Partner Organizations: Set all partner organizations to Inactive.

  5. External Users: Set all study monitor assignments to Inactive.

  6. Products: Set all study products to Inactive.

  7. Study Team Assignments:
  8. Archive Study:
    • Set the state of the study to Archived.
    • If you’re a SiteVault Enterprise customer with the Vault Archive feature enabled and configured for your vault, move the study-specific documents to the Vault Archive.

  9. Export Study Documentation: If applicable, export study documents per your site’s record-keeping SOPs.

Managing Study Participants
Overview of Documents
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