subchapter_subject: "TOXIC SUBSTANCES CONTROL ACT (CONTINUED)"
part_code: "792"
part_subject: "GOOD LABORATORY PRACTICE STANDARDS"
subpart_code: "B"
subpart_subject: "Organization and Personnel"
section_number: "792.33"
section_subject: "Study director."
cfr_reference: "40 CFR 792.33"
title_name: "Title 40"
title_subject: "Protection of Environment"
parts_covered: "Parts 790 to 999"
revised_date: "Revised as of July 1, 2019"
publication_date: "As of July 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"
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For each 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 § 792.120 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 study are noted when they occur, and corrective action is taken and documented.