New FDA Protocol Deviation Guidance:  Planning for the Things That Don’t Go According to Plan

A systematic, proactive, and carefully considered approach to protocol deviations is a powerful tool in drug development with direct impacts on the interpretability of clinical trial results. The direction provided by strong SOPs and work practices for protocol deviations facilitates decision making, accuracy of Clinical Study Reports, and optimal positioning of Marketing Applications.    

For sponsors considering best practices for assessment and reporting of protocol deviations, the December 2024 FDA guidance provides a great resource. The guidance provides advice, as well as specific examples, to assist in defining Important Protocol Deviations and highlights the roles and responsibilities of sponsors, investigators, and IRBs in monitoring, mitigating, and reporting protocol deviations.  

Sponsors will benefit from having a single point of reference for the most important regulatory considerations relating to protocol deviations.   

If you are interested in ensuring alignment with the best practices delineated in this guidance, our MMS Quality and Compliance team can support you in creating or updating relevant SOPs and work practices. As noted by MMS Associate Director of Quality and Compliance Jennifer Perrin: “Well-written SOPs facilitate compliance with regulatory requirements, enhancing the reliability and credibility of the organization’s processes and outcomes. That doesn’t mean they have to be overly burdensome. Rather they should be fit-for-purse with where an organization is currently at within their drug approval journey.” 

Additionally, our experienced medical writing teams can ensure that important protocol deviations are accurately reported in Clinical Study Reports. Email info@mmsholdings.com for further information.