Feature Article: The Art And Science Of Auditing Clinical Trials

By Douglas R. Mackintosh and Vernette J. Molloy

Clinical auditing, in the context of pharmaceutical and biotech studies, is a systematic process not unlike financial auditing done by certified public accountants. It involves objectively obtaining and evaluating data and the evidence related to that data. In the case of clinical auditing, however, the data are related to assertions about medical actions and events and subsequent data processing and how well those data and evidence correspond to established criteria such as generally accepted principals of good clinical practice (GCP). The process culminates with communicating those results to interested users.1 Key ingredients of both financial and clinical auditing include independence to express negative findings and the avoidance of conflicts of interest.

Clinical auditors as scientists try to eliminate the subjective, unreal, imaginary elements from their work to obtain an objective, "true" picture of reality.2 The scientist describes what events and phenomena are and attempts to objectify quality using standards and guidelines (e.g., FDA Code of Federal Regulations). That classic approach to auditing yields findings typical to many studies: protocol violations, discrepancies and mismatches in data, site staff that said one thing but did another, and discrepancies in testimony about study activities among site staff.

Reprinted with permission from BioExecutive International 2(6):S40-46 (June 2006)

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