According to the ICH Guideline for Clinical Safety Data Management, a serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization (other than for drug administration) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect.
The aim of this standardised procedure is to identify, assess, report, and follow serious adverse events occurring in study patients enrolled in an antimalarial drug efficacy trial.
This procedure is intended for use in clinical trials where antimalarial treatment is being administered to patients. It is designed to be modified to reflect the needs of specific study sites.
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