Regulatory Implications of Protocol Deviations and How to Avoid the Pitfalls
*Carolyn Finkle, InVentiv Health Clinical 


When the Agency receives a sponsor NDA/BLA, FDA will conduct a biomedical monitoring inspection of the sponsor-investigator’s practices and procedures to determine compliance with U.S. regulations and ICH Good Clinical Practice. Protocol changes can be made during the course of the study in a prospective and planned manner. These changes are included in a protocol amendment and are implemented in a systemic fashion following IRB review and submission to FDA. On the other hand a protocol deviation is generally an unplanned excursion from the protocol. Although protocol deviations may occur during the conduct of a clinical trial, they need to be minimized and will also require review and approval by the IRB and communicated to FDA. Importantly, protocol deviations can impact the integrity of the trial conduct and may result in inspectional findings. This session will discuss the regulatory impact of protocol deviations and how sponsors can minimize study integrity impact.