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Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online.

FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice

Visit this FDA page to search through years of answers to GCP related questions on:

  • Adverse Events Inquiries
  • Computer Questions
  • Device Study Inquiries
  • FDA Forms 1571 and 1572
  • Financial Disclosure Inquiries
  • Foreign Studies Inquiries
  • Good Clinical Practice Inquiries
  • Health Insurance Portability and Accountability Act Questions
  • Human Subject Protection Inquiries
  • Informed Consent Inquiries
  • Inspection Questions
  • Institutional Review Board Questions
  • Recordkeeping and Record Retention
  • Special Populations Inquiries
  • Training and Qualifications

Responses to inquiries prior to 2013 can be found in the FDA Archive.

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