Certification For Principal Investigator
The Association of Clinical Research Professionals (ACRP) provides a certification, specific to physician investigators/principal investigators (PIs). ACRP offers the designation "Certified Physician Investigator (CPI)".
In a study published by David Vulcano of Hospital Corporation of America, CPI certification has been shown to be a valid predictor of overall regulatory compliance based on comparing outcomes of FDA inspections between those that were CPI certified investigators to those that were not CPI certified. Specifically over the three year timeframe of the analysis, approximately 12% of FDA audits of investigators who were not CPI certified have resulted in an Official Action Indicated (OAI) classification, where there had been zero instances of OAI results among CPI certified investigators; this was statistically significant (p=<.001). Similarly, more than 50% of the inspections of CPI certified investigators yield No Action Indicated (NAI) results, compared to only 35% of investigators not certified by the Academy; this separation was also statistically significant (p=<.005). Other studies have had similar findings. Industry sponsors have considered CPI certification of investigators as an acceptable means of demonstrating competency in Good Clinical Practices
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