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

Question: 1 / 400

What does a failure to follow the randomization procedure during a study raise during an audit?

Concern regarding the study's validity

A failure to follow the randomization procedure during a study raises significant concern regarding the study's validity. Randomization is a critical aspect of research design, especially in clinical trials, as it helps ensure that the groups being compared are as similar as possible, reducing the potential for bias. When randomization is not properly implemented, the integrity of the data can be compromised, leading to questions about the reliability of the study's conclusions. As a result, auditors will scrutinize the adherence to randomization protocols, given that deviations can impact the overall results and interpretations of the study, ultimately questioning the validity of the findings. This concern can affect the credibility of the research and its acceptance in the scientific community.

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