Summary of Federal Regulations Applicable to Clinical Research

Federal Regulation of Clinical Research

Department of Health & Human Services
(DHHS)

National Institute of Health (NIH)

Food & Drug Administration (FDA)

Search the CFR

Search Title 21 CFR

45 CFR DHHS

21 CFR Food & Drug

1. Part 46 Human Subjects Protection “The Common Rule”
2. Parts 160 & 164, HIPAA
   
3. Part 94 Conflict of Interest – Government Contracts

1. Part 11 Electronic Records/Signatures
2. Part 50 Human Subjects Protection
3. Part 54 Financial Disclosure by Clinical Investigators
4. Part 56 IRBs
5. Part 312 IND Applications
6. Part 314 New Drug Applications
7. Part 600 Biological Products, General
8. Part 803 Medical Device Reporting
9. Part 812 Investigational Device Exemption
10. Part 814 Pre-market Approvals for Medical Devices

1. Part 58 GLP for Non-clinical Lab
2. Part 210 cGMP
3. Part 211 cGMP Finished Pharmaceutical
4. Part 820 Quality System Regulation (QSR)