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Adverse Event Reporting for Drugs by Sponsors
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Item Number: NWRR3020
A ten-page procedure that describes the process, as it applies to the company as a sponsor, for recording, evaluating, and reporting adverse events that occur during clinical trials for drugs. This document assigns responsibility for each step of the procedure and applies to all clinical trials for an investigational drug product under a FDA approved Investigational New Drug (IND).
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