In December 2024, the FDA published a draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.” This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. It emphasizes identifying deviations that could impact participant safety or data integrity, ensuring a consistent approach across studies.

Key highlights include:

• Clear Definitions: Introducing terms like “important protocol deviations” to enhance understanding and alignment.
• Sponsor and Investigator Roles: Clarifying responsibilities in assessing and managing deviations.
• Focus on Data Quality: Providing strategies to minimize deviations and mitigate their potential impact on trial outcomes.

This draft offers valuable insights for optimizing clinical trial oversight while safeguarding data quality and participant safety.

Stakeholders have until 28-February-2025, to submit feedback.

FDA Draft Guidance – PDs for Clinical Investigations