A Review of the Source Document Verification Process in Clinical Trials
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0092-8615/99 Copyright 0 1999 Drug Information Association Inc.
A REVIEW OF THE SOURCE DOCUMENT VERIFICATION PROCESS IN CLINICAL TRIALS MALCOLM L. SCHUYL, BSc Head, Clinical Compliance, Asia Pacific and Japan Regions, Glaxo Wellcome plc, United Kingdom
THIMENGEL,MD Medical Director, Glaxo Wellcome plc, Denmark
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 Key Words: Good clinical practice; Clinical trials; Source data; Study monitor; Access; Document verification
INTRODUCTION THE PROPER MONITORING of clinical studies involves ensuring that reliable information is reported back to the sponsor. This includes the activity generally known as source document verification which is an integral part of the good clinical practice requirements worldwide. There has been some information published already on this subject, but there is still much misunderstanding and uncertainty. This paper attempts to bring all the relevant Reprint address: Malcolm L. Schuyl, BSc. Head, Clinical Compliance, Asia Pacific and Japan Regions, GlaxoWellcome plc. Greenford. Middlesex, United Kingdom UB6 OHE.
information together, to enable an effective and appropriate SDV system to be designed and implemented.
BACKGROUND There is a requirement for all physicians (as well as other health professionals such as dentists) investigating or treating patients to document all relevant findings and changes to current therapy. Clinical trials are undertaken to investigatehest clinical hypotheses in a systematic way. For every patient participating in such trials, all findings and changes to current therapy need to be documented in the same way as if they were done as part of everyday clinical practice-utside a clinical trial.
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Mrilcolm L. Schuvl and Thim Engel
In order to ensure the accuracy of the data, it is of the utmost importance to exclude incorrect data. This should be done by preventing care
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