Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance

The commenter suggests that the draft guidance should more clearly specify that deviations occurring at the study level or due to protocol omissions should be reported by the sponsor rather than individual sites. They argue that sites lack the necessary information to provide meaningful root cause analyses for such issues and request more nuanced reporting requirements for minor deviations.

EMD Serono, the healthcare business of Merck KGaA, supports the draft guidance but proposes several specific refinements to improve clarity and practical implementation. They suggest narrowing the definition of "protocol" to avoid excessive reporting, clarifying the role of investigators, and recommending a separate, structured monitoring approach for protocol deviations related to safety events.