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Informed Consent Document Templates

 SECTION 18

Protocol Deviations and Violations

All protocol deviations and violations must be reported to the Human Assurance Committee (HAC) within five (5) business days. Submit a description of the deviation and/or violation in memo format along with a completed HAC Form 120.

Violations affect a subject’s rights, safety or well-being or data integrity.  It may also affect primary safety or efficacy endpoints of the study.  Examples are:

• enrolling subjects who did not meet entry criteria without prior permission of the sponsor/CRO
• failing to obtain informed consent prior to any study-related procedures
• failure to treat subjects according to protocol procedures that specifically relate to primary safety or efficacy endpoints

Deviations generally do not have a major impact on subject’s welfare or data integrity.  Examples of deviations are scheduling a required procedure outside of the time frame specified in the protocol because the subject was on vacation when the procedure should have occurred or subject use of a prohibited concomitant medication.  

Elisabeth Clark, Research Ethics Officer/Human Protections Administrator of McGill University Health Center provides the following clarification:

"Protocol Violation - A term broadly used in clinical research to describe any study event whereby the current HAC approved research protocol was not followed, i.e. a change in a research activity.  There is a general acceptance in the biopharmaceutical industry for two categories of protocol violation, protocol exception and protocol deviation."

"Protocol Deviation - A divergence or departure from the expected conduct of an approved study that is not consistent with the current research protocol, consent document or study addenda that had not been anticipated.  All protocol deviations must be reported in writing to the HAC immediately upon discovery.

Urgent action to eliminate an immediate hazard to a subject is the only acceptable protocol deviation, and the event must be explained in writing to the sponsor, and to the HAC, as soon as possible."

"Protocol Exception - A divergence or departure from expected conduct of an approved study that is not consistent with the current research protocol, consent document or addenda, that had been anticipated by the investigator, and for which HAC grants acceptance."

Submit a completed HAC Form 120, Protocol Deviation/Violations,  with a memo outlining each incident as well as what has been done to prevent the deviation/violation from occurring again. If events were not reported in a timely manner, include the reason for the reporting delay. Submit this information to the HAC office at CJ-2103.

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February 20, 2007