A Suspected Unexpected Serious Adverse Reaction is known as a SUSAR.
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Sometimes during a clinical trial for a specific investigational product, there may be serious adverse reactions in subjects given the drug, that may or may not be dose-related, but are unexpected, as they are not consistent with current available information.
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However, there are some grey areas with regards to submission timelines to investigators and how to demonstrate safety reports review and dissemination by investigators that are not covered by ICH E2A but discussed along this article.
The distribution follows well-defined pathways described in ICH E2A 1. Since the main objective of pharmacovigilance is the identification of information that may affect the safety of patients, once a potential risk is noted, it must be communicated to all stakeholders.
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This helps to supplement member dues and continue to provide valuable member benefits to our members.ARE YOU LOST IN GCP? DOWNLOAD OUR FREE PDF GUIDE! All adverse drug reactions (ADRs) that are both serious and unexpected (Suspected Unexpected Serious Adverse Reactions, SUSARs) are subject to expedited reporting. In 2000, over $1.1 million was generated resulting in an excess of 85% gain. In addition, the IEEE generates considerable revenue from this service.
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