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# FDA Guidance on Good Clinical Practice Principles
- URL: https://www.fdaweb.com/fda-guidance-on-good-clinical-practice-principles/
- Published: 2025-09-08T12:00:00.000Z
- Updated: 2026-09-14T15:21:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159826

FDA has issued an updated guidance entitled [*E6(R3) Good Clinical Practice (GCP)*](https://www.fda.gov/media/169090/download?ref=fdaweb.com) that describes GCP principles, emphasizing flexible, modern approaches to clinical trial design and conduct while maintaining participant safety and data integrity. The guidance, aligned with the International Council for Harmonization, notes that well-designed and well-executed clinical trials are essential for developing new medicines and ensuring evidence-based healthcare decisions. Poorly designed or poorly run trials, the agency warns, can expose participants to unnecessary risk, generate unreliable results, and waste valuable resources.

The agency states that the principles are meant to be adaptable to a wide range of studies, from traditional randomized controlled trials to newer designs incorporating digital health technologies. Tools such as wearables and sensors, the agency says, could enable the collection of diverse data sources, provided their use is tailored to the trial’s objectives, participant population, and clinical setting.

The guidance also encourages trial sponsors to seek input from patients, advocacy groups, and healthcare professionals early in the design process. Incorporating these perspectives, FDA says, can reduce unnecessary complexity, improve feasibility, and make study results more broadly applicable to real-world patient populations.

Key to the revised framework is a “quality by design” approach, in which sponsors proactively identify the data and processes most critical to trial success and address the risks that could undermine them. Risk mitigation strategies, FDA advises, should be proportional to both the importance of the data being collected and the risks to participants’ safety.

The overarching principles apply throughout the life cycle of a trial, and while they are interdependent, the agency stresses they should be considered together to ensure ethical conduct and reliable results.