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Protocol Deviation Form

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Protocol Deviation Form

A protocol deviation is a departure from the approved protocol’s procedures made without prior IRB approval. Some examples include, enrolling participants who do not meet the inclusion criteria; additional or modified research procedures; subjects signing an incorrect consent form version or document that does not contain the IRB approved stamp.

Researchers are to report the deviation to OPRS as soon as it is discovered. The form details specific information necessary for IRB review.