Change Study PI

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Changing the 91探花PI for an approved study requires a modification in Zipline. In addition to updating the PI field, other basic questions in the application must be answered.

If the study is registered on ClinicalTrials.gov through the UW, contact聽hsdreprt@uw.edu regarding the PI change. Put聽CT.gov聽in the subject line for efficient triage of your message.

When the modification is approved, the changes are published into the approved study and the new PI is granted access to the Zipline application.

How to Change Study PI

Review these instructions if you need to change the PI for a single site external IRB study or an external IRB study created before January 7, 2020.

  • Click Modify Study in the study workspace
    • For studies reviewed by a non- 91探花IRB, click Create Site Modification

screenshot of the modify study button

  • Indicate that the purpose of the submission is modification/update, the scope is 鈥淥ther parts鈥�, and select Continue
    • Zipline only allows one active modification of each type at a time. If there is already an open modification to 鈥淥ther parts鈥� either incorporate the PI change into the open modification or wait until the open modification has been approved and then submit a new modification to 鈥淥ther parts of the study.鈥�

screenshot of the modification form with other parts of the study selected

  • Include the reason for the PI change in Question 3, and click Continue

  • Click the ellipsis to update the Local Principal Investigator Field to the new PI

screenshot of the ellipsis button

  • Make any other changes to the application that may be needed based on the PI change
    • EXAMPLE: For 91探花reviewed studies, if the consent form lists the old PI and is still in use, make sure to upload a new version listing the new PI
  • Select Save and Exit out of the draft SmartForm once your changes are complete

  • After exiting the draft SmartForm, you are in the Modification Workspace. The modification workspace lists the new Principal Investigator but the new PI will not have access until the modification is approved.
  • From the Modification Workspace, the PI or PI proxy must click Submit to send the modification for HSD review

screenshot of the submit button

Once HSD has approved the modification, the study workspace will reflect the new PI and any other changes made.

Change PI for a Single Site External IRB Study or an External IRB Study Created Before January 7, 2020

  • Click Update Study Details in the site workspace

screenshot of the update study details button

  • 2. Indicate that there is a 91探花PI change in the update summary

screenshot of the study update information page

  • You are now in a draft version of the study SmartForm and should be on the Basic Information page. Update the draft version of the study to reflect the change in PI.
    • On the Basic Study Information page, click the ellipsis to change the local principal investigator to the new PI

screenshot of the ellipsis button

  • Email hsdrely@uw.edu when the update is complete. HSD staff will finalize the update after your change has been assessed.