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Duties and Responsibilities of Study Personnel
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Item Number: NWRR4061
A procedure that defines the duties and responsibilities of study personnel as they apply to a nonclinical laboratory study. This procedure applies to all nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). This eight-page document discusses study personnel’s duties and responsibilities with respect to personal hygiene, maintenance of laboratory areas and equipment, receiving and handling of test and control articles, data entry and documentation, and conduct during audits.
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