REPORTING PROTOCOL DEVIATIONS UNDER IND
(Information adapted from MAGI Journal of Clinical Research Best Practices) FDA’s regulations have numerous references to “changes” or “amendments” to study protocols. For example, 21 CFR 312.30 addresses the responsibility of sponsors to submit amendments to their IND(s) to ensure that clinical investigations are conducted according to protocols included in the application. 21 CFR 312.30(b) specifically discusses changes in a protocol, and provides several examples of changes that would require sponsors to submit protocol amendments to the IND. However, the FDA regulations do not provide specific guidances on deviation reporting.
A protocol deviation directed at eliminating an apparent immediate hazard to a research subject or group of subjects may be implemented immediately but must be reported to the IRB as "reportable new information" as soon as possible but no later than 5 business days.
The respective protocol deviation should be addressed in the next Annual Report to the IND application. If the protocol deviation will be incorporated as a permanent change (i.e., revision) to the protocol, a respective Protocol Amendment must be submitted prospectively to the IND application/FDA. The revision to the protocol must be approved by the IRB before it can be implemented.
REPORTING PROTOCOL DEVIATIONS UNDER IDE
FDA device regulations at 21 CFR 812.150(a)(4) discuss protocol deviations under IDE regulations. An investigator shall notify the sponsor and the IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible but no later than 5 days after the emergency occurred. Except in such an emergency, the IRB must approved protocol deviations, or changes, before they can begin. The FDA must be made aware in accordance with 21 CFR 812.35(a).