What is the difference between a Protocol Deviation and an Amendment?
A – An amendment is a change or changes that are premeditated, intentional, and occur prior to implementation. Therefore, prior to any change in the protocol the submission of an amendment is required. It should be noted that the Committee approves a study in its totality. Once altered, the study is no longer that which the Committee approved. Therefore, the Principal Investigator cannot change a study prospectively without an approved amendment. To do so, would alter a study from one approved by the IRB to a study that has not been approved.
Related Questions
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