Certified Clinical Research Associate (CCRA) Practice Exam 2026 – Complete Preparation Guide

The term used for a serious adverse event that occurs in a clinical study is known as an Adverse Drug Reaction (ADR). An ADR is defined as any harmful and unintended response to a medicinal product, which occurs at doses normally used for prophylaxis, diagnosis, or therapy. In clinical research, it is crucial to distinguish ADRs from other types of events due to their implications for patient safety and regulatory requirements.

While the other options represent concepts related to clinical research, they serve different purposes. A Serious Event Report (SER) typically documents any serious adverse event encountered but does not specifically define the event itself as an ADR. Clinical Trial Declaration refers to the formal assertions related to the conduct of a trial, and a Patient Safety Report is a broader document that may include various types of data on patient safety without the specific focus on adverse drug reactions. Therefore, ADR accurately encapsulates the definition of a serious adverse event in the context of clinical studies.