CFR section
21 CFR 56.115(a)(2): IRB records
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart D-Records and Reports
Key facts
| Citation | 21 CFR 56.115(a)(2) |
|---|---|
| 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, Food/Cosmetics, General |
| Regulation text (excerpt) | (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. |
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.