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FDA Regulations Relating to Good Clinical Practice (GCP) and Clinical Trials
August 8, 2006
Electronic Records; Electronic Signatures (21 CFR Part 11)
Human Subject Protection (Informed Consent) (21 CFR Part 50)
Financial Disclosure by Clinical Investigators (21 CFR Part 54)
Institutional Review Boards (21 CFR Part 56)
Investigational New Drug Application (21 CFR Part 312)
Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
Applications for FDA Approval of a Biologic License (21 CFR Part 601)
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