part_subject: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
subpart_code: "B"
subpart_subject: "Organization and Personnel"
section_number: "58.33"
section_subject: "Study director."
cfr_reference: "21 CFR 58.33"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.