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GCP Questions E-Mail Messages

Last updated March 28, 2008
(2002 files added; 2003 files, 2004 files and 2005 files remain unchanged from previous postings)

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.

  • 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

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