Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The term SUSAR stands for "Suspected Unexpected Serious Adverse Reaction." This definition is crucial in the field of clinical research as it refers to adverse events that are serious in nature, occur unexpectedly when considering the nature of the drug or intervention, and are suspected to have a causal relationship with the treatment. Recognizing and correctly classifying SUSARs is vital for ensuring patient safety and for regulatory reporting, as these events require prompt attention and investigation.

The components of the term each contribute important meanings: "Suspected" indicates that there is a preliminary belief that the drug may be related to the adverse event, "Unexpected" means that the reaction is not consistent with the risks outlined in the clinical trial or product labeling, and "Serious" refers to outcomes that result in significant consequences, such as hospitalization, disability, or death. Understanding this term helps clinical research associates assess and monitor the safety profile of interventions being studied.