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

Question: 1 / 400

What is the primary function of source documents in a clinical trial?

They summarize the findings for regulatory submissions

They serve as the official record of study procedures

The primary function of source documents in a clinical trial is to serve as the official record of study procedures. These documents include patient medical records, laboratory reports, and other original records that capture the details of the data generated during the trial. They provide the foundational evidence of what occurred during the study, including participant enrollment, treatment administration, and any adverse events.

Source documents are critical for establishing the integrity of the data collected and ensuring that it is verifiable and traceable throughout the audit and regulatory processes. They support the findings reported in clinical study reports and are essential during inspections by regulatory authorities. By properly documenting all trial-related information, source documents ensure accountability and transparency, ultimately contributing to the credibility of the trial’s results.

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They provide data for statistical analysis

They are used to communicate with IRBs

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