21 CFR Subpart D
Responsibilities of Sponsors and Investigators
June 25, 2020
§
312.69
Handling of controlled substances
§
312.70
Disqualification of a clinical investigator
§
312.66
Assurance of IRB review
§
312.50
General responsibilities of sponsors
§
312.68
Inspection of investigator's records and reports
§
312.52
Transfer of obligations to a contract research organization
§
312.53
Selecting investigators and monitors
§
312.54
Emergency research under §50.24 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
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