US · BIMO · CDER · CBER
FDA
U.S. Food & Drug Administration
17 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.
§ 01 — Agency portal
AGENCY PORTAL · FDA FDA Bioresearch Monitoring Program — Compliance Programs
The agency's own GCP hub — navigation and resources beyond the documents
catalogued below.
opens on fda.gov ↗ § 02 — Documents
FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections NEW GUIDANCE 2025 PDF · — FDA E6(R3) Good Clinical Practice — Final Guidance for Industry GUIDANCE 2025 PDF · 2.1 MB FDA Bioresearch Monitoring Program — Clinical Investigators and Sponsor-Investigators CP 7348.811 COMPLIANCE PROGRAM 2025 PDF · — FDA Bioresearch Monitoring Program — Institutional Review Boards NEW CP 7348.809 COMPLIANCE PROGRAM 2025 PDF · 293 KB FDA Decentralized Clinical Trials for Drugs, Biological Products, and Devices GUIDANCE 2024 PDF · 650 KB FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations Draft GUIDANCE 2024 PDF · 880 KB FDA Electronic Records; Electronic Signatures 21 CFR Part 11 REGULATION 2024 LINK · — FDA Financial Disclosure by Clinical Investigators NEW 21 CFR Part 54 REGULATION 2024 LINK · — FDA Institutional Review Boards 21 CFR Part 56 REGULATION 2024 LINK · — FDA Investigational New Drug Application 21 CFR Part 312 REGULATION 2024 LINK · — FDA Protection of Human Subjects 21 CFR Part 50 REGULATION 2024 LINK · — FDA Bioresearch Monitoring Program — Sponsors, Contract Research Organizations, and Monitors CP 7348.810 COMPLIANCE PROGRAM 2023 PDF · 1.4 MB FDA A Risk-Based Approach to Monitoring of Clinical Investigations — Questions and Answers NEW Q&A 2023 PDF · — FDA Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations — Questions and Answers NEW Draft Q&A 2023 PDF · — FDA Electronic Source Data in Clinical Investigations GUIDANCE 2013 PDF · 380 KB FDA Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring GUIDANCE 2013 PDF · 720 KB FDA Computerized Systems Used in Clinical Investigations GUIDANCE 2007 PDF · 420 KB