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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i4
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 312
    PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
  5. subpart D
    Subpart D—Responsibilities of Sponsors and Investigators

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.
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