Regulations Relating to Clinical Trials

Here are links to regulations governing human subject protection and the conduct of clinical trials.

USFDA:

Electronic Records; Electronic Signatures (21 CFR Part 11)
Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
Financial Disclosure by Clinical Investigators (21 CFR Part 54)
Institutional Review Boards (21 CFR Part 56)
Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
Investigational New Drug Application (21 CFR Part 312)
Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
New Animal Drugs for Investigational Use (21 CFR Part 511)
New Animal Drug Applications (21 CFR Part 514)
Applications for FDA Approval of a Biologic License (21 CFR Part 601)
Investigational Device Exemptions (21 CFR Part 812)
Premarket Approval of Medical Devices (21 CFR Part 814)
EMEA(European Region):

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation/

CDSCO India:
https://cdsco.gov.in/opencms/opencms/en/Home/

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