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Duties and Responsibilities of the Study Director
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Item Number: NWRR4041
An eight-page procedure that defines the duties and responsibilities of the Study Director 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 document includes the sponsor’s duties and responsibilities prior to initiation of the study, during the study, and at completion of the study.
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