21 CFR 58.130: Conduct of a nonclinical laboratory study
Requires nonclinical lab studies to follow the protocol, with monitored test systems, properly labeled specimens, gross necropsy findings available to pathologists, and data recorded promptly, signed, dated, with changes traceable and original entries preserved.
Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies · Subpart G, Protocol for and Conduct of a Nonclinical Laboratory Study
Recent 483s citing 58.130
- Merck Sharp & Dohme LLC · West Point, PennsylvaniaNot all nonclinical laboratory studies were conducted in accordance with the… Apr 30, 2019
- ASEGUA THERAPEUTICS LLC · Foster City, CaliforniaFailure to document all aspects of study conduct… Dec 9, 2011
The regulation text
§ 58.130 Conduct of a nonclinical laboratory study.
(a)The nonclinical laboratory study shall be conducted in accordance with the protocol.
(b)The test systems shall be monitored in conformity with the protocol.
(c)Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
(d)Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.
(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 change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]
Questions
What does 21 CFR 58.130 require?
Requires nonclinical lab studies to follow the protocol, with monitored test systems, properly labeled specimens, gross necropsy findings available to pathologists, and data recorded promptly, signed, dated, with changes traceable and original entries preserved.
Which sections are cited alongside 58.130?
In the same 483s, investigators most often also cite 58.190 (Storage and retrieval of records and data).