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 [email protected] 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
- Human Subject Protection Inquiries
- Informed Consent Inquiries
- Inspection Questions
- Institutional Review Board Questions
- Recordkeeping and Record Retention
- Special Populations Inquiries
- Training and Qualifications