CFR section
21 CFR 58.120(b): Protocol
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart G-Protocol for and Conduct of a Nonclinical Laboratory Study
Key facts
| Citation | 21 CFR 58.120(b) |
|---|---|
| Section | Protocol |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart G-Protocol for and Conduct of a Nonclinical Laboratory Study |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol. |
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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.