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

The data reported on the Case Report Form (CRF) must be consistent with source documents. Source documents are the original records or certified copies of original records that contain the first-hand or primary data related to the trial participants. They include medical records, hospital charts, laboratory reports, and notes on visits, among other documents.

Consistency with source documents ensures that the data captured on the CRF accurately reflects the actual observations and findings from these primary records. This is crucial for maintaining data integrity, reliability, and validity, as the CRF serves as a standardized instrument for collecting and reporting clinical data during a clinical trial.

While current good manufacturing practices, clinical guidelines, and site-specific protocols play important roles in clinical research, they do not directly dictate how individual data points on the CRF must correlate with each other. Instead, those frameworks guide the overall conduct of the study, regulatory compliance, and the general treatment protocols or methodologies. The CRF's accuracy is primarily tied to the source documents, representing the cornerstone of clinical data verification and integrity.