Responsibilities of Sponsors and Investigators

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Investigational New Drug Application
  7. Responsibilities of Sponsors and Investigators

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Section
312.50

General responsibilities of sponsors.

Section
312.52

Transfer of obligations to a contract research organization.

Section
312.53

Selecting investigators and monitors.

Section
312.54

Emergency research under § 50.24 of this chapter.

Section
312.55

Informing investigators.

Section
312.56

Review of ongoing investigations.

Section
312.57

Recordkeeping and record retention.

Section
312.58

Inspection of sponsor's records and reports.

Section
312.59

Disposition of unused supply of investigational drug.

Section
312.60

General responsibilities of investigators.

Section
312.61

Control of the investigational drug.

Section
312.62

Investigator recordkeeping and record retention.

Section
312.64

Investigator reports.

Section
312.66

Assurance of IRB review.

Section
312.68

Inspection of investigator's records and reports.

Section
312.69

Handling of controlled substances.

Section
312.70

Disqualification of a clinical investigator.