What protocol deviations or violations are required to be reported?
Protocol deviations or violations that either increase the risk to subjects or affect the integrity of the study data must be reported to the IRB. IRBs deem any deviation/violation from the protocol that increases the risk to subjects or affects the integrity of the study data to be significant. An isolated issue may not be significant by itself but significance may increase with numerous deviations of the same nature. Significant deviations may be events such as: enrollment of subjects who did not meet inclusion/exclusion criteria, use of the wrong informed consent document, or failure to perform appropriate procedures at a study visit. Submissions should be made on the IRB’s Protocol Deviation Report Form and Investigators should submit information to the IRB within 10 working days after becoming aware of a significant protocol deviation.
Protocol deviations or violations that either increase the risk to subjects or affect the integrity of the study data must be reported to the IRB. IRBs deem any deviation/violation from the protocol that increases the risk to subjects or affects the integrity of the study data to be significant. An isolated issue may not be significant by itself but significance may increase with numerous deviations of the same nature. Significant deviations may be events such as: enrollment of subjects who did not meet inclusion/exclusion criteria, use of the wrong informed consent document, or failure to perform appropriate procedures at a study visit. Submissions should be made on the IRB’s Protocol Deviation Report Form and Investigators should submit information to the IRB within 10 working days after becoming aware of a significant protocol deviation.
