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Regulations last checked for updates: May 15, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 312
Subpart D - Subpart D—Responsibilities of Sponsors and Investigators
§ 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 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.
source:
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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