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The Good Laboratory Practice Regulations 1997
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Reporting of study results
14.—(1) Purpose: To determine whether final reports are prepared in accordance with good laboratory practice principles.
(2) When a final report is available, the inspector should check that—
it is signed and dated by the study director and, where appropriate, by other principal scientists,
the study director has signed a statement indicating acceptance of responsibility for the validity of the study and confirming that the study was conducted in accordance with good laboratory practice principles,
a quality assurance statement is included in the report and that it is signed and dated,
any amendments were made by the responsible personnel,
it lists the archive location of all samples, specimens and raw data.
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