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.
Categories FDA Regulatory