Studies

Manage the teams, vendors, and participants for your studies

Initiate Study Archive

Who can complete this task?
  • Administrators

Note The Archive Study action cannot be reversed. A study in the Archived state cannot move to another state.

The Archive Study action consists of a series of automated study status checks and several attestations that the action initiator (Site Administrators) must complete. For more information on what occurs when you archive a study, see Study Archive Overview.

  1. Access Studies.
  2. Select the study.
  3. Select View Study Details.
  4. Select All Actions (…).
  5. Select Archive Study.
  6. Review the Archive Readiness page for the following:
    • No study documents need to be approved
    • No study documents have open/pending workflows
    • All study participants are in the Inactive state
    • Team Assignments are in the Inactive state (specific to studies using Digital Delegation)
  7. Resolve any outstanding readiness checks. Once all criteria are met, select Next.
  8. Review and complete the Archival Attestations.
  9. Complete the End of Study Date field.
  10. Complete the Retention Period field.
  11. Select Archive Study.
  12. Carefully review the content of the Final Study Archive Confirmation.
  13. Select Continue.

The number of participants and documents factor into the archival processing time.

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