Modify the Approved Study

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Before You Begin

Do you need to change who has access to your application in Zipline?

Go to Manage Study Access for more information.

Do you need to submit a modification?

Whether you need to submit a modification depends on the initial review.

  • Some changes always require HSD to review a modification and make a re-determination of exempt status. Many other changes do not.
  • For more details on when to submit a modification for exempt research review the Exempt Research Guidance.

Any changes to the approved application must be submitted to HSD and approved by the UW IRB before you implement the change.

Review Overview of the Modification Process for an overview and Modifications to UW Reviewed Studies for detailed steps.

Overview of the Modification Process

After a UW IRB application has been approved, changes must be made using the study modification process.

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 as part of the main study record.

Zipline categorizes modifications into 2 types. One active modification of each type is allowed at a time, although multiple changes can be made within one modification. The modification types are:

  • Study team member information (changes to who can view and edit the study in Zipline)
  • Other parts of the study (all other parts of the application – such as changing the PI and updating the IRB protocol or other documents)

For detailed steps review Modifications to UW Reviewed Studies.

For information on modifying multi-site studies and relying sites, review Multi-site Modifications.

 

What to Expect After Submitting

Once HSD has reviewed the modification, the PI, any PI proxies, and primary contact will receive a notification that:

  • HSD has approved the modification and no additional action is needed at this time; OR
  • HSD requires more information or a change before approving the modification

After the modification is approved, the changes are published in the study record, so the study always contains the currently approved information. The PI, PI proxy, and primary contact also receive a notification containing the modification approval letter.