Q – 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.
Alternatively, a protocol deviation does not occur as a deliberate, purposeful change to an approved protocol. It is an unplanned, unintended change to the protocol, which is a written plan. Sometimes an unplanned change will happen due to patient error, incidental oversight by the study staff, or to protect patient safety or welfare. It is for these occasions that the category of protocol deviation was designed. If this occurs it should be reported on a Protocol Deviation Form (#1123).
