Understanding What are the 4 elements of ICSR? A Guide to Pharmacovigilance
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4 min read
According to the National Institutes of Health (NIH), a valid Individual Case Safety Report (ICSR) must contain four minimum criteria to be reportable to regulatory bodies. This critical component of pharmacovigilance is designed to monitor drug safety by identifying and reporting adverse drug reactions and is centered around understanding what are the 4 elements of ICSR.
