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. The responsibilities of both the investigational team and the sponsor in SDV must be made clear at the outset of the trial. Considerations such as access to data and confidentiality must be fully addressed, so that there are no misunderstandings or surprises when SDV is undertaken. Records of what was done and found, including an evaluation of the findings, must be made, in the same way as for any other aspect of the trial. There must also be a recognition that SDV really adds value to a trial, but this can only be effectively achieved if everyone fully appreciates the objectives associated with SDV.