Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance

A Clinical Operations Lead at a global CRO supports the draft guidance but requests specific clarifications regarding the definition of "immediate hazards to human subjects." The commenter argues that hazards preventable by stopping or not initiating the use of an investigational product should not be classified as "immediate" to ensure proper protocol amendments and IRB approvals.

The National Center for Health Research, a nonprofit public health think tank, supports the draft guidance but argues that it needs to be even more specific and objective to ensure the integrity of clinical research results. They urge the FDA to provide clear instructions on deviations that could bias data, such as those affecting blinding and randomization, rather than loosening requirements.