21 CFR 58.33: Study director
Requires each nonclinical lab study to have a qualified study director who is the single point of control, responsible for technical conduct, data integrity, protocol compliance, GLP adherence, corrective actions, and archiving of study records.
Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies · Subpart B, Organization and Personnel
Recent 483s citing 58.33
- BASF Corporation · East Setauket, New YorkThe study director failed to assure that all raw data and documentation were… May 29, 2025
- U.S. Army Medical Research Institute of · Fort Detrick, MarylandThe study director failed to assure that all experimental data, including… Jan 21, 2015
- Alcon Research LLC · Fort Worth, TexasThe study director failed to assure that all experimental data, including… Jul 24, 2014
- Joinri'Laboratories Co., Ltd · Beijing, ChinaThe study director failed to assure that the protocol, including any change, was… Sep 20, 2013
The regulation text
§ 58.33 Study director.
For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:
(a)The protocol, including any change, is approved as provided by § 58.120 and is followed.
(b)All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c)Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
(d)Test systems are as specified in the protocol.
(e)All applicable good laboratory practice regulations are followed.
(f)All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]
Questions
What does 21 CFR 58.33 require?
Requires each nonclinical lab study to have a qualified study director who is the single point of control, responsible for technical conduct, data integrity, protocol compliance, GLP adherence, corrective actions, and archiving of study records.
Which sections are cited alongside 58.33?
In the same 483s, investigators most often also cite 58.190 (Storage and retrieval of records and data), 58.35 (Quality assurance unit), 58.63 (Maintenance and calibration of equipment), 58.81 (Standard operating procedures).