21 CFR Part 312, Subpart D - Responsibilities of Sponsors and Investigators

eCFR
Authorities (U.S. Code)

§ 312.50 General responsibilities of sponsors.
§ 312.52 Transfer of obligations to a contract research organization.
§ 312.53 Selecting investigators and monitors.
§ 312.54 Emergency research under § 50.24 of this chapter.
§ 312.55 Informing investigators.
§ 312.56 Review of ongoing investigations.
§ 312.57 Recordkeeping and record retention.
§ 312.58 Inspection of sponsor's records and reports.
§ 312.59 Disposition of unused supply of investigational drug.
§ 312.60 General responsibilities of investigators.
§ 312.61 Control of the investigational drug.
§ 312.62 Investigator recordkeeping and record retention.
§ 312.64 Investigator reports.
§ 312.66 Assurance of IRB review.
§ 312.68 Inspection of investigator's records and reports.
§ 312.69 Handling of controlled substances.
§ 312.70 Disqualification of a clinical investigator.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 355 - New drugs

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 371 - Regulations and hearings

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 262 - Regulation of biological products