Change Study PI

Changing the UW 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.

When a study modification is created, a draft version of the study is created with the proposed changes, while the approved study remains unchanged. When the modification is approved, the changes are published into the approved study and the new PI is granted access to the Zipline application.

Change Study PI Steps

Note: See these instructions ^[2] if you need to modify the study team for an external IRB study created before January 7, 2020.

1. Click Modify Study in the study workspace

• NOTE: For studies reviewed by a non-UW IRB, click Create Site Modification

2. Indicate that the purpose of the submission is modification/update

3. Indicate “Other parts” as the scope of the modification and click Continue

• NOTE: The system only allows one active modification of each type at a time. If there is already an open modification to “Other parts” 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 “Other parts of the study.”

4. Complete the Modification Information SmartForm page, including the reason for the PI change in Question 3, and click Continue

5. 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.

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

1. • Make any other changes to the application that may be needed based on the PI change

• • • EXAMPLE: For UW 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

6. Click Save and Exit out of the draft SmartForm once your changes are complete

7. After exiting the draft SmartForm, you are in the Modification Workspace. The modification workspace will list the new Principal Investigator but the new PI will not have access until the modification is approved.

8. After completing the modification, the original PI or a PI proxy must complete the Submit activity to send the modification to HSD for review

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

Studies Reviewed by an External IRB and Created Before January 7, 2020

1. Click Update Study Details in the site workspace

2. Indicate that there is a UW PI change in the update summary

3. 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.

1. • On the Basic Study Information page, click the ellipsis to change the local principal investigator to the new PI

• • Click Save and Exit out of the draft SmartForm once your changes are complete

4.  Email hsdrely@uw.edu ^[3] when the update is ready to be finalized. HSD staff will finalize the update after your change has been assessed.