The Association of Clinical Research Professionals (ACRP) has published a comprehensive set of core competency guidelines for Principal Investigators (PIs) and Sub Investigators.
Functional Competency Guidelines for Principal and Sub Investigators is an important contribution to ACRP’s growing set of resources aimed at translating the Joint Task Force for Clinical Trial Competency guidelines into role-specific guidelines.
“U.S. Food and Drug Administration regulations and Good Clinical Practice guidelines set the expectation that PIs are ‘qualified by training and experience,’ but most investigators do not receive formal training in clinical research and the GCP training they are provided by partner institutions is not competency-based,” says Jim Kremidas, ACRP Executive Director. “By offering a comprehensive set of practical competency guidelines and actionable steps that those interested in getting into clinical research can follow, we hope to set PIs on a path to success in clinical trials.”
The guidelines were developed by a multi-stakeholder working group of ACRP’s Workforce Innovation Steering Committee whose representation includes experienced PIs from a wide range of practice settings, as well as stakeholders involved in PI training, and support and oversight (IRB/QA/QC).
“Thanks to the leadership and contributions of such a wide range of stakeholders, these guidelines represent a comprehensive view of the most essential core competencies needed from PIs and Sub Investigators,” Kremidas adds. “Most of the resources and training available to PIs focus on the ‘what’ and ‘why’ of clinical trial conduct but fail to address the ‘how.’ By translating major tasks into competency statements, we believe this set of guidelines addresses a significant gap in terms of setting expectations for PI competency and how to best structure the training and mentoring of new investigators.”
“Guidelines for investigator research competency reflect an ideal way to ensure clinical treatment algorithms and PI training are all aligned and equally represented for the betterment of patient care,” says working group member Dr. Anita S. Kablinger, MD, CPI, FAAP, FAPA, FACRP, Professor and Program Director Clinical Trials Research, Department of Psychiatry and Behavioral Medicine, Carilion Clinic-Virginia Tech Carilion School of Medicine, Virginia Tech Faculty of Health Sciences.
“In clinical research, ignorance can be a crime and our PI competency guidelines will stimulate all key players and PIs to stay well-informed of best practices, ICH guidelines, and regulations,” adds working group member Dr. Gualberto C. Perez, MD, CPI, CEO, Founder and President, GCP Research.
Today’s announcement follows recent publication by the ACRP WISC of the following guidelines:
- Core Competency Guidelines for Clinical Research Coordinators
- Core Competency Framework for Clinical Trial Monitoring
- Hiring Guidelines for Entry Level Clinical Research Coordinators
Learn more about ACRP’s initiatives.