Science & Research

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 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 2014 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
  • Human Subject Protection Inquiries
  • Informed Consent Inquiries
  • Inspection Questions
  • Institutional Review Board Questions
  • Recordkeeping and Record Retention
  • Special Populations Inquiries
  • Training and Qualifications


Page Last Updated: 03/14/2019
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