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Revised: 10/2013-Page 1 of 4Protocol Amendments Introduction: The IRB reviews and approves all amendments (i.e., revisions, modifications, or addenda) to an IRB approved research protocol. Definition: Amendment
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Protocol amendments are changes made to the research protocol after it has been approved by the Institutional Review Board (IRB).
The principal investigator or study team is responsible for filing protocol amendments with the IRB.
Protocol amendments can be filled out by completing the necessary forms provided by the IRB and following the specific instructions for submission.
The purpose of protocol amendments is to ensure that any changes made to the research protocol are reviewed and approved by the IRB to protect the rights and welfare of research participants.
Protocol amendments must include a detailed description of the changes being made to the research protocol, the rationale for the changes, and any potential risks or benefits associated with the changes.
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