A Review of the Source Document Verification Process in Clinical Trials

Confirming that accurate and reliable information has been reported by the investigator to the sponsor during clinical trials is a fundamental requirement of good clinical practice (GCP), and there can be significant implications if this is not undertaken appropriately. Yet, there is still much uncertainty surrounding this process, generally referred to as source document verification (SDV). This paper attempts to identify and discuss the main considerations to enable an effective and appropriate SDV system to be implemented.