DEVELOPING SYSTEMS FOR COST-EFFECTIVE AUDITING OF CLINICAL-TRIALS

Auditing a clinical trial is a complex process designed to ensure that the trial will provide a reliable answer to the question being posed. Traditional auditing methods are expensive, and escalate the cost of clinical trials. This paper describes approaches to cost-effective mon itoring of clinical trials, such as integrating them with clinical pra ctice and focusing the data being collected. Sampling methods for sour ce documentation can be used to eliminate costs incurred by reviewing every record. These measures, coupled with prospective clinical judgme nt about areas of concern in the conduct of trials, can reduce complic ations and costs without sacrificing quality. (C) Elsevier Science Inc . 1997.