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        Clinical Trials and Human Subject Protection

Good Clinical Practice Inquiries Home
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          Clinical Trials and Human Subject Protection
          Good Clinical Practice InquiriesClinical Trials and Human Subject Protection Good Clinical Practice Inquiries
  	
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    PrintFDA 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

Resources

Good Clinical Practice | FDA
	Good Clinical Practice Educational Materials | FDA
	Clinical Trials and Human Subject Protection | FDA

                                                                                  Content current as of:
      06/20/2023Good Clinical Practice Inquiries
 
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