CFR section
21 CFR 58.130(e): Conduct of a nonclinical laboratory study
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 58.130(e) |
|---|---|
| Section | Conduct of a nonclinical laboratory study |
| 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 | Devices, Drugs, General |
| Regulation text (excerpt) | (e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the… |
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