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Chapter 10 - Serious Adverse Event (SAE)

Chapter 10 - Serious Adverse Event (SAE) Serious Adverse Event (SAE) reporting constitutes one of the most important safety elements of any clinical trial. It is the joint responsibility of investigator(s) and sponsor(s) to report all the valid SAE to the respective IRB/IEC/EC and regulatory body (ies) in a timely and accurate fashion as per the applicable Adverse Event has been defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with this treatment.

FORM FDA 3500A (6/10) For use by user-facilities, importers, distributors and manufacturerers for MANDATORY reporting A. PATIENT INFORMATION B. ADVERSE EVENT OR PRODUCT PROBLEM C. SUSPECT PRODUCT(S) D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER Mfr Report# UF/Importer Report# FDA Use Only 1. Name (Give labled strength & …

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Transcription of Chapter 10 - Serious Adverse Event (SAE)

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