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  1. Clinical Trials and Human Subject Protection

Good Clinical Practice Inquiries

FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations. The agency’s oversight of clinical trials protects the rights, safety, and welfare of people participating in clinical trials, and supports the development of safe and effective medical products. The agency addresses inquiries related to good clinical practice and human subject protection policies on an ongoing basis. The downloadable spreadsheet below includes inquiries that have been submitted to the FDA as well as the agency’s replies to each inquiry and is searchable by different fields such as topic, date, etc.

See the FDA archive for inquiries from 2013 to 2017 and inquiries prior to 2013. Contact gcpquestions@fda.hhs.gov with questions.

Good clinical practice inquiries and responses 2018 - 2022



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