1. The Federal Register

The Office of the Federal Register, part of the National Archives and Records Administration, publishes regulations in the Federal Register, the official “newspaper” of the federal government, every work day. The office annually compiles all current regulations into the bound volumes of the Code of Federal Regulations (CFR). ...

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Congress enacted the Federal Register Act (FRA) in July of 1935. The FRA created the Federal Register as the official daily publication for presidential documents and executive agency rule and notice documents and established a central location for filing documents for public inspection.

The Federal Register contains four sections:

Presidential Documents
Rules and Regulations
Proposed Rules
Notices

Source: Amy Bunk. Federal Register 101. The Coast Guard Proceedings. Spring 2010; 55-57. (Public Domain.)

The second section, Rules and Regulations, contains the current rules resulting from federal laws--this section also includes all of the regulations for clinical trials. These and other regulations are also compiled, annually in the Code of Federal Regulations (CFR). FDA regulations are found in Title 21 CFR - Food and Drugs.

2. The Code of Federal Regulations (CFR)

A few volumes of the Code of Federal Regulations.

Source: Code of Federal Regulations, Coolcaesar. Wikimedia Commons. (Creative Commons Attribution.)

The printed copy of the Code of Federal Regulations includes many volumes. Thankfully, you can now find up-to-date, current regulations by topic in the eCFR. Watch these short videos to learn how to use the eCFR.

2.1 Master the CFR: Intro to the Code of Federal Regulations (1:27 minutes)

Source: Office of the Federal Register. Master the CFR: Intro to the Code of Federal Regulations. NARA, USA. Sept. 25, 2014. (Public Domain.)

2.2 Master the CFR: Researching the Code of Federal Regulations (9 minutes)

Source: Office of the Federal Register. Master the CFR: Researching the Code of Federal Regulations. NARA, USA. Sept. 25, 2014. (Public Domain.)

2.3 For updates to regulations, check the eCFR for the most current version (5:06 minutes)

Source: Federal Depository Library Program. The e-CFR or Electronic Code of Federal Regulations. 2019. Retrieved from: https://www.fdlp.gov/govinfo-tutorials-2 (Public Domain.)

3. FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations. These laws and regulations are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects. (FDA, USA. Good Clinical Practice. Dec. 11, 2019.)

Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects. The Food and Drug Administration (FDA) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. (FDA, USA. Clinical Trials and Human Subject Protection. Aug. 12, 2020.)

These regulations are published in a variety of 21 CFR chapters. The FDA provides links to the most relevant sections on its website (but don't forget to check the eCFR for updates.)

Visit: Regulations: Good Clinical Practice and Clinical Trials.

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)

3.1 The Principles of the ICH GCP

Clinical trials often include international participation. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) created the Good Clinical Practices (GCP) as:

"an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible." (FDA, USA. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry. March 2018.)

3.2 What's the point of all these regulations? (9:55 minutes)

Source: Bridget Foltz, FDA, USA. Clinical Investigator Training Course held on November 13-15, 2018, in Silver Spring, Maryland. Retrieved from: https://cersi.umd.edu/clinical-investigator-training-course/2018 (Public Domain.)

4. Don't Forget to Share the Knowledge!