Transcription of Chapter 10 - Serious Adverse Event (SAE)
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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.
1. Investigator Site to Sponsor/CRO; lICH-GCP recommendations: Immediately 2. Investigator Site to Ethics Committee; lICH-GCP recommendations: As per the applicable regulations 3. Sponsor/CRO to Regulatory Agency; lICH-GCP recommendations: a) Fatal or life-threatening unexpected adverse drug reactions- Within 7 calendar days
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