Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance

Boehringer Ingelheim Pharmaceuticals, Inc. provides specific technical comments and proposed revisions to the draft guidance on protocol deviations for clinical investigations. The company seeks to clarify reporting timeframes, the distinction between safety and data integrity issues, and the classification of deviations at the site versus participant level.

Dr. Bo E. H. Saxberg, representing DDO Strategic Services, LLC, supports the draft guidance and suggests a more nuanced classification system for protocol deviations. He proposes a 2x2 categorization based on importance and predictability (Expected vs. Unexpected) to better align with modern industrial process control and risk-based monitoring.

The Medical Device Manufacturers Association (MDMA) supports the FDA's effort to establish a uniform system for classifying protocol deviations in clinical studies. They suggest specific improvements to the draft guidance, including clarifying terminology, refining the categorization of certain deviations, and providing more detailed instructions on data handling and reporting procedures.

The LUNGevity Foundation, a lung cancer nonprofit, supports the draft guidance on protocol deviations, noting that some flexibility is appropriate for maintaining trial integrity. They request additional clarification on how the volume and level (e.g., patient vs. site) of deviations impact their classification as "important" and suggest refining reporting requirements to avoid undue burdens for minor deviations.

Florence’s Site Enablement League, representing clinical research sites and sponsors, supports the draft guidance but requests additional clarifications. They specifically seek more detail on classifying GCP compliance issues as deviations, reducing administrative burdens related to protocol amendments, and streamlining IRB reporting requirements.

The N2 Network of Networks is requesting clarification on the terminology used in the draft guidance regarding protocol deviations. They specifically ask whether the term "important" is intended to replace or serve as a category for terms like "major," "critical," and "significant," and request specific examples for each classification due to ambiguity.

Laboratory Corporation of America Holdings (Labcorp), a global life sciences company, submitted comments regarding the draft guidance on protocol deviations for clinical investigations. The company supports the guidance but requests further clarification on reporting requirements for "important" and "other" protocol deviations, specifically suggesting the use of international terminology and clearer definitions for administrative deviations.