When to Report SUSARs to Regulatory Authorities
When to Report SUSARs to Regulatory Authorities Determining When to Report SUSARs in Clinical Trials What Is a SUSAR? A Suspected Unexpected Serious Adverse Reaction (SUSAR) is an event that meets three critical criteria: it is serious, it is related to the investigational product, and it is unexpected compared to the Investigator’s Brochure (IB) or…
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