CFR section
21 CFR 312.68: Inspection of investigator's records and reports
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.68 |
|---|---|
| Section | Inspection of investigator's records and reports |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do… |
At a glance
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.