Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Question: 1 / 400

What is required for an adverse drug reaction to be classified as an ADR?

The event must be severe

A causal relationship must be unlikely

A reasonable possibility of a relationship must exist

For an adverse drug reaction (ADR) to be classified as such, there must be a reasonable possibility of a causal relationship between the drug and the adverse event. This means that based on the evidence available, the likelihood that the drug caused the adverse reaction must be significant enough to warrant consideration as an ADR. The definition emphasizes that the reaction should not be attributed to factors unrelated to the medication, ensuring that there is enough correlation between the drug's use and the adverse outcome.

In this context, the severity of the event or whether it aligns with the product information are important considerations but do not directly determine whether something is classified as an ADR. Moreover, stating that a causal relationship is unlikely contradicts the very premise of identifying an ADR. Therefore, the presence of a reasonable possibility is essential for classifying an event as an ADR.

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The event must be consistent with product information

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