Regulations

• FDA Regulations Relating to Good Clinical Practice and Clinical Trials
• Preambles to GCP Regulations

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

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FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human animal subjects

• 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)
• Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (21 CFR Parts 50 and 56)
• Informed Consent Elements (21 CFR 50.25(c))
• Exception From General Requirements for Informed Consent (21 CFR 50.23(e))
• 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)
• Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)
• Expanded Access to Investigational Drugs for Treatment Use (PDF - 216KB)
• Charging for Investigational Drugs (PDF - 204KB)
• Form 1571 (Investigational New Drug Application)
• Form 1572 (Statement of Investigator)
• 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)

Preambles to GCP Regulations

Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process.

The "preamble" to each of these publications includes all of the printed information immediately preceding the codified regulation. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments . The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation (as the case may be) of the regulation.

The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

Parts 50 and 56

• Protection of Human Subjects, Standards for Institutional Review Boards for Clinical Investigations (August 8, 1978)
• Protection of Human Subjects; Informed Consent (January 27, 1981)
• Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations (January 27, 1981)
• Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations (January 27, 1981)
• Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations (November 1988)
• Federal Policy for the Protection of Human Subjects (June 18, 1991)
• FDA Policy for the Protection of Human Subjects (June 18, 1991)
• Protection of Human Subjects; Informed Consent; Proposed Rule (September 21, 1995)
• Protection of Human Subjects; Informed Consent, Part II (October 2, 1996) [html]
• Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules (October 2, 1996) [text]
• Protection of Human Subjects; Informed Consent (December 22, 1995)
• Protection of Human Subjects; Informed Consent Verification; Final Rule (November 5, 1996)
• Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure (November 9, 1998)
• Protection of Human Subjects; Informed Consent, Exception from general requirements (October 5, 1999)
• Additional protections for children (66 FR 20589-600, April 24, 2001)
• Exception from General Requirements for Informed Consent (71 FR 32827, June 7, 2006) [PDF]
• FDA IRB Registration Requirements (21 CFR 56.106); Proposed Rule; (69 FR 40556, July 6, 2004)
• FDA IRB Registration Rule (21 CFR 56.106) [text version] | [Printable PDF version] (74 FR 2358, January 15, 2009)

Part 54

• Financial Disclosures by Clinical Investigators (63 FR 5233, February 2, 1998)
• Financial Disclosures by a Clinical Investigator(63 FR 72171-81, December 31, 1998)

Part 210

• Current Good Manufacturing Practice Regulations and Investigational New Drugs (January 17, 2006)

Parts 312 and 314

• Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations (June 9, 1983)
• New Drug and Antibiotic Regulations (February 22, 1985)
• New Drug, Antibiotic, and Biologic Drug Product Regulations (March 19, 1987)
• Investigational New Drug Applications and New Drug Applications (September 8, 1995)
• Investigational New Drug Applications and New Drug Applications (February 11, 1998)
• Disqualification of a Clinical Investigator (February 16, 1996)
• Disqualification of a Clinical Investigator (September 5, 1997)
• Expedited Safety Reporting Requirements for Human Drug and Biological Products (October 7, 1997)
• Clinical Hold for products intended for life threatening conditions (65 FR 34963-71, June 1, 2000)
• Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (September 29, 2010)
• Disqualification of a Clinical Investigator (April 30, 2012)

Part 320

• Retention of BE and BA testing samples (April 28, 1993)
• Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (September 29, 2010)

Part 812

• Quality System Regulations (October 7, 1996)
• Treatment Use of Investigational Devices (September 18, 1997)
• Withdrawal of Intraocular Lenses Regulation (Part 813) (January 29, 1997)
• Disqualification of Clinical Investigators (March 14, 1997)
• Modifications to the List of Recognized Standards (July 12, 1999)
• Modifications to the Medical Device and/or Study Protocol (November 23, 1998)
• Disqualification of a Clinical Investigator(April 30, 2012)

Part 814

• Medical Devices; Humanitarian Use Devices Part V (June 26, 1996)
• 30-Day Notices and 135-Day PMA Supplement Review (October 8, 1998)
• Humanitarian Use of Devices (November 3, 1998)

Miscellaneous

• Part 11 Electronic Records; Electronic Signatures (March 20, 1997)
• Use of Bioresearch Monitoring Information System (BMIS) (63 FR 55873-6, October 19, 1998)
• Presiding officer (66 FR 45317-8, August 28, 2001)