After the review of an initial application has been completed, changes can be made using the study modification process. Typically, study modifications are submitted for studies that have received IRB approval, but modifications may also be submitted for studies with other determinations if needed. See this short video for an overview of the modification process [2].
When a study modification is created, a draft version of 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 submission. The modification types are:
- Study team member information (changes to who can view and edit the study)
- Other parts of the study (all other parts of the application, including the study PI)
See Update Study Team [3] for detailed information on study team member modifications and Change Study PI [4] for detailed information on changing the study PI.
See UW Reviewed Studies [5] for detailed instructions on modifications to other parts of the study.
See Changing External IRB Studies [6] to learn how to make changes to studies reviewed by a non-UW IRB.
Modifications Overview Video
Watch this short video for an overview of modifications in Zipline.