Subpart D—Responsibilities of Sponsors and Investigators

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 312
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9. Subpart D

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

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