CFR section
21 CFR 58.120(a): 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(a) |
|---|---|
| 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) | (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the test and control articles by name, chemical abstract number, or code number. (3) The name of the sponsor and the name and address of the testing facility at which the study is being conducted. (4)… |
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