CFR section
21 CFR 56.115(b): IRB records
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart D-Records and Reports
Key facts
| Citation | 21 CFR 56.115(b) |
|---|---|
| Section | IRB records |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart D-Records and Reports |
| Subchapter | 21 CFR A General |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (b) The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.