A Message from the University of Pittsburgh Institutional Review Board
IRB Announcements
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How to use the reviewer notes to add justification for each change in a modification
Following the completion of the Modification Coversheet, you will need to make the necessary changes to your protocol and/or consent document(s). You are also required to provide a justification for the requested changes.
After you click on the "View Modifiable Study" button, you will note a yellow header at the top each page titled "Reviewer Notes." Click on the "Add" button and provide the justification for the requested changes. You will need to provide a separate justification for each page modified or it will be returned to you. You must provide a scientific and/or clinical rationale for the requested changes.
Based on your responses, Osiris will request pre-IRB reviews if applicable (e.g., fiscal review, scientific review, rDNA review). Remember that changes to the protocol may also necessitate changes to the consent form(s) and/or other study documents.