Protocol Deviation

Protocol Deviation

A protocol deviation is a departure from the study design or procedure that has not been approved by the IRB and does not have a major impact on the subject’s rights, safety or well being, or the accuracy and reliability of the study data. A common protocol deviation is when researchers do not use the TC IRB approved and stamped consent forms. To avoid such administrative deviations (and the need for a report to IRB), follow the parameters outlined in your IRB protocol and use official documentation for all study activities.

In order to submit a protocol deviation, log in to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Click My Protocols, and select the protocol you would like to modify. Once that page loads, scroll down and click the Protocol Deviations tab. Click New Protocol Deviation

A researcher is required to submit detailed documentation of the protocol deviation, along with a corrective action plan, explaining what will be done to prevent reoccurrence. Protocol deviations require prompt reporting and must be submitted no later than five days after the deviation. It is important for researchers to be as thorough in their explanation as possible; full disclosure will give the IRB staff the best chance at assisting them in their research. An IRB staff member, or the full board, must review and acknowledge the deviation before the researcher can interact with human subjects or data collection can resume. Further action on the researcher's end may be requested by the IRB staff; these decisions are made on a case-by-case basis.

Please review our How to Submit a Modification, Continuing Review, Adverse Event, and Deviation document for more detailed instructions and information on this topic.

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