Title 21

PART 312 SUBPART D

Subpart D - Responsibilities of Sponsors and Investigators

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
• 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

21:5.0.1.1.3.4.1.1	SECTION 312.50	312.50 General responsibilities of sponsors.
21:5.0.1.1.3.4.1.2	SECTION 312.52	312.52 Transfer of obligations to a contract research organization.
21:5.0.1.1.3.4.1.3	SECTION 312.53	312.53 Selecting investigators and monitors.
21:5.0.1.1.3.4.1.4	SECTION 312.54	312.54 Emergency research under § 50.24 of this chapter.
21:5.0.1.1.3.4.1.5	SECTION 312.55	312.55 Informing investigators.
21:5.0.1.1.3.4.1.6	SECTION 312.56	312.56 Review of ongoing investigations.
21:5.0.1.1.3.4.1.7	SECTION 312.57	312.57 Recordkeeping and record retention.
21:5.0.1.1.3.4.1.8	SECTION 312.58	312.58 Inspection of sponsor's records and reports.
21:5.0.1.1.3.4.1.9	SECTION 312.59	312.59 Disposition of unused supply of investigational drug.
21:5.0.1.1.3.4.1.10	SECTION 312.60	312.60 General responsibilities of investigators.
21:5.0.1.1.3.4.1.11	SECTION 312.61	312.61 Control of the investigational drug.
21:5.0.1.1.3.4.1.12	SECTION 312.62	312.62 Investigator recordkeeping and record retention.
21:5.0.1.1.3.4.1.13	SECTION 312.64	312.64 Investigator reports.
21:5.0.1.1.3.4.1.14	SECTION 312.66	312.66 Assurance of IRB review.
21:5.0.1.1.3.4.1.15	SECTION 312.68	312.68 Inspection of investigator's records and reports.
21:5.0.1.1.3.4.1.16	SECTION 312.69	312.69 Handling of controlled substances.
21:5.0.1.1.3.4.1.17	SECTION 312.70	312.70 Disqualification of a clinical investigator.

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