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THE PHARMA REVIEW (JULY – AUGUST 2014)

Safety Assessment and Reporting in a Clinical Trial

Rakesh Kumar Rishi

Introduction: As per recently inserted para 5(A)(1) of Schedule Y, “A serious adverse event is an untoward medical occurrence during clinical trial that is associated with death, in patient hospitalisation (in case the study was being conducted on out-patient), prolongation of hospitalisation (in case the study was being conducted on in-patient), persistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life threatening”. 

 

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