Digital Delegation

Learn how to digitize your Delegation of Authority log

Study End - Closing the Delegation Log

Who can complete this task?
  • Administrators

At the end of a study, a Site Administrator can initiate the closing of the Digital Delegation Log. This process should only be initiated once all delegation information has been entered and/or updated. NOTE: Completing this process removes the ability to update responsibilities and delegations.

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Start Delegation Log Closure

To initiate closing the delegation log, complete the steps below.

  1. Access Study > Team.
  2. Enter an End Date for the Principal Investigator (PI).
    • Select the Principal Investigator.
    • Select Edit.
    • Complete the End-Date-Time field.
    • Select Save.
  3. Review delegations for final updates.
    • Access Study > Manage Delegations.
    • Optionally, update Version Details.
    • Select Delegations.
    • Select Edit Delegations to add or update Start or End Dates. Save any changes.
    • Select Generate Delegation Log.
  4. Send for PI approval.
    • Access the Delegation Log document (if not automatically directed).
    • Select the Workflow Menu (chevron).
    • Select Send for PI Approval.
    • Enter a Document Date and the PI Approval Due Date.
    • Select Start. The PI will receive a task to approve and sign the document. Once signed, the document will update to Current.
  5. Once the PI completes their approval, complete an additional final review. NOTE: The remaining step to disable Digital Delegation from the study is necessary for archival. This step will not impact the existing log (it will remain Current), however it removes the ability to make changes to the study’s responsibilities or delegations; any future changes to the log must be completed manually.
  6. Disable Digital Delegation on the study.
    • Access Study > View Study Details.
    • Update the Digital Delegation Log dropdown to Disabled.
    • Ensure the following:
      • All updates have been applied to the log.
      • The PI assignment has an end date.
      • The final PI signature has been applied.
      • The document is in the Current state.
    • If the above list is true, select Continue. The PI’s study team assignment remains Active, however all other previously-Active team assignments are moved to Proposed. Team members requiring study access until archival can be moved back to Active as needed.
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