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  1. Clinical Trials and Human Subject Protection

Replies to Inquiries to FDA on Good Clinical Practice

This page is designed to simplify the search for copies of e-mail messages (including the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program's gcp.questions@fda.hhs.gov e-mail account. The e-mail messages have been redacted to the extent permitted by the Freedom of Information Act and sorted into topic folders, which are updated on a continuing basis. The folders are prepared as self-extracting zip files that may be saved to your computer and opened, and the e-mail messages are saved in PDF format, which may be read with a free copy of Adobe Acrobat Reader.

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

  • 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