Protocol Deviations: A Holistic Approach from Defining to Reporting

Defining and processing protocol deviations (PD) can be complex and varied, and present challenges for several stakeholders within the clinical trial ecosystem.  Improvements in protocol deviation management, and reporting processes can aid those conducting clinical research in a variety of ways including: rapid identification of important protocol deviations and assessing potential or real impact of COVID-19 on their specific study.

To address various challenges, TransCelerate’s Protocol Deviations (PD) Initiative team recently published an article, “Protocol Deviations: A Holistic Approach from Defining to Reporting.”  The publication identifies key principles to build upon and clarify the definition of a protocol deviation and describes a holistic approach to their management. These approaches are adapted to suit a variety of indications, study designs, and investigational agents while supporting consistent application within a study, program, or organization.

This paper further bolsters TransCelerate’s Protocol Deviations Toolkit and delves into the various solutions that the Protocol Deviations Initiative has developed and help outline an end-to-end process flow.

I hope you enjoy reading the paper and find the step-by-step guide on the Protocol Deviations solution page useful.

Laura is the co-lead of the Protocol Deviations Workstream and is Director, Global Clinical Trial Operations at Merck & Co., Inc. She is a member of TransCelerate BioPharma’s Oversight Committee. This Committee is the governing body for decisions related to the clinical portion of the portfolio, including project sponsorship. Laura draws on her experience as an Operations Director for a busy therapeutic area and as head of a performance and analytics group to provide this perspective. Internally, she has responsibility for driving engagement, and facilitating adoption or internalization of TransCelerate solutions in alignment with Merck’s objectives. Additionally, she watches for opportunities to match innovative approaches to process improvement initiatives or other areas of focus.