Can Investigator Certification Improve the Quality of Clinical Research?

Abstract

With costs and competitive pressures increasing, pharmaceutical sponsors and contract research organizations are examining the drug development process. Investigators who conduct clinical studies significantly impact research quality and, thereby, costs. This article reviews current investigator selection methods and their shortcomings. Using one organization's experience certifying clinical research coordinators and clinical research associates, the authors highlight certification as a means of assessing competency and discuss investigator certification as a potentially accurate indicator of competence for conducting research and as a predictor of inherent quality at the research site.