Digital Delegation

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. Any future changes to the log must be made manually.

Start Delegation Log Closure

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

1. Access Study > Team.
2. Select View Study Details.
3. From the Actions menu, select Start Delegation Log Closure.
4. Review the Close Delegation Log process.
5. Select the Closure Date and Time to apply to all team assignments and delegations without an End Date/Time or with an End Date/Time that is past the Closure Date/Time.
6. Select Generate Delegation Log. The PI is sent a task to review and eSign the delegation log.
7. PI reviews the Delegation Log and selects one of the following:
   • Approves the log and applies their eSignature.
   • Rejects the log for additional edits and the closure process must start again.
8. 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.
9. 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 final PI signature has been applied.
     • The document is in the Current state.
   • If the above list is true, select Continue.
10. Update Study Team Assignments to Inactive.