CPI™ Certification as Predictor of Clinical Investigators’ Regulatory Compliance

Abstract

Hospitals, research sponsors, institutional review boards, and other stakeholders do not have data to support a universal “test” to ensure that a clinical investigator is not only adequately trained in the International Conference on Harmonization Good Clinical Practices but can implement those principles into practice. Many stakeholders have created their own training programs of vastly different content and quality with little to no reciprocity. This has led to waste in the industry as well as qualified investigators having to retake basic courses because of the lack of reciprocity or globally accepted mark. In addition, investigators who may not be as well versed as they should be often are left to continue in their role because of the lack of efficacy evaluation of what training they received. The Certified Physician Investigator (CPI™) certification put forth by the Academy of Pharmaceutical Physicians and Investigators is poised to be that standard yet is not widely accepted as it is relatively new, and thus its effectiveness as a predictor of regulatory compliance needs to be studied.