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Discrepancies between the Case Report Form (CRF) and source documents must be explained because ensuring data integrity is critical in clinical trials. The CRF serves as the primary data collection tool used in clinical research, and it is essential that the information recorded on the CRF accurately reflects the information obtained from source documents, such as medical records or lab reports.

When discrepancies arise, they can impact the interpretation of study results, compromise the reliability of the data, and potentially lead to incorrect conclusions about the efficacy or safety of an investigational product. By explaining these discrepancies, researchers can clarify the reasons behind the differences, whether they stem from data entry errors, changes in clinical findings, or other factors. This explanation contributes to transparency in the research process and supports adherence to regulatory and ethical standards.

It is also essential for maintaining clinical trial quality and for verification during audits or inspections by regulatory authorities. Addressing discrepancies appropriately allows for ongoing quality control and provides a clear audit trail, which is crucial in clinical research governance.