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

Source data, as defined by the ICH (International Council for Harmonisation) guidelines, should be considered reliable and verifiable. This emphasis on reliability means that the data collected during clinical trials or research studies must come from a trustworthy source that can be confirmed and validated through various means, such as audits or checks. Verifiability ensures that the data can be traced back to its original source and confirmed as accurate, thus supporting the integrity of the research findings.

The notion of reliability is critical for maintaining the quality and credibility of clinical research, as any misleading or inaccurate data could compromise study results, regulatory compliance, and ultimately patient safety. Therefore, adherence to these principles encourages the implementation of proper data management practices, which include thorough documentation and systematic oversight.

In contrast, the other choices suggest negative attributes or conditions surrounding source data that do not align with the expectations set forth in ICH guidelines. Seeing source data as flawed, invalid, or adjustable undermines the fundamental requirement for robust, high-quality data in clinical research.