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Sponsor Reporting Requirements for Drugs
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Item Number: NWRR3019
A 13-page procedure that describes regulatory reporting requirements as they apply to the sponsor for clinical investigations of a drug or biologic. This procedure applies to all clinical investigations of a drug or biologic intended for submission to the Food and Drug Administration (FDA) and to the reports required during the conduct of the clinical investigation of a drug or biologic. These reports include:
IND safety reports; annual reports; financial reports, monitoring reports, safety and efficacy monitoring reports; clinical study trial reports; and internal and external quality assurance audit reports.
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