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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21 - Food and Drugs
  4. CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER D - DRUGS FOR HUMAN USE
  6. PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION
  7. Subpart D - Responsibilities of Sponsors and Investigators

21 CFR Subpart D - Responsibilities of Sponsors and Investigators

  • CFR
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  1. § 312.50 General responsibilities of sponsors.
  2. § 312.52 Transfer of obligations to a contract research organization.
  3. § 312.53 Selecting investigators and monitors.
  4. § 312.54 Emergency research under § 50.24 of this chapter.
  5. § 312.55 Informing investigators.
  6. § 312.56 Review of ongoing investigations.
  7. § 312.57 Recordkeeping and record retention.
  8. § 312.58 Inspection of sponsor's records and reports.
  9. § 312.59 Disposition of unused supply of investigational drug.
  10. § 312.60 General responsibilities of investigators.
  11. § 312.61 Control of the investigational drug.
  12. § 312.62 Investigator recordkeeping and record retention.
  13. § 312.64 Investigator reports.
  14. § 312.66 Assurance of IRB review.
  15. § 312.68 Inspection of investigator's records and reports.
  16. § 312.69 Handling of controlled substances.
  17. § 312.70 Disqualification of a clinical investigator.

The following state regulations pages link to this page.



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