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Deviation Reporting
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Item Number: NWRR4093
A procedure that describes the method for documenting deviations, planned and unplanned, in a nonclinical laboratory study. This procedure applies to deviations in nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). This 11-page document, including two attachments (Deviation Report and Deviation Report Log), assigns responsibility for each step of the procedure.
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