Table 2.

U.S. Food and Drug Administration regulations related to good clinical practice and clinical trials

21 CFR Part 11	Electronic Records; Electronic Signatures
21 CFR Part 50	Human Subject Protection (Informed Consent)
21 CFR Part 50, subpart D	Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
21 CFR Part 54	Financial Disclosure by Clinical Investigators
21 CFR Part 56	Institutional Review Boards
21 CFR Part 312	Investigational New Drug Application
Forms 1571 and 1572	Investigational New Drug Application and Statement of Investigator
21 CFR Part 314	Applications for FDA Approval to Market a New Drug
21 CFR Part 601	Applications for FDA Approval of a Biologic License
21 CFR Part 812	Investigational Device Exemptions
21 CFR Part 814	Premarket Approval of Medical Devices