202 Unlocking potential: Introducing the PI Badge, a micro-credential for clinical trial investigators

Abstract

Objectives/Goals: Competencies of a principal investigator (PI) in clinical research are crucial for ensuring the success, integrity, and ethical conduct of a study. This protocol aims to assess training offerings focused on improving clinical investigator competency and build a set of best practices for training. Methods/Study Population: The authors have started by creating a committed group of key opinion leaders at Rutgers Health and across industry to advise on the process. A mixed-method assessment of the current state of clinical investigator training/education in the conduct of T1-T4 clinical trials is currently being conducted to identify existing practices. An evaluation and assessment of key competencies will be initiated. Education and training objectives and modules will subsequently be developed from this process. The program will be piloted to early career clinicians, faculty, fellows, investigators within NJACTS, and other CTSAs and later assessed for efficacy. Results/Anticipated Results: A summary and descriptive statistics of the landscape of training opportunities and the variabilities of these offerings to address the needs of these investigators is projected to exhibit the gaps in knowledge and skill set required for a PI to effectively conduct a clinical trial. This will serve as the basis for developing a micro-credential (PI Badge) by the NJACTS’ Workforce Development group. Variability across educational offerings from academic institutions, sponsor/CRO protocol/study training, and online courses may not foster applicable skills. This badge is focused on addressing a clinician’s understanding of the roles and responsibilities as they align to the Principal Investigator commitments listed in the FDA form 1572. Discussion/Significance of Impact: Whether or not micro credentialing will enhance principal investigator competency, this mixed-method assessment is poised to identify a common benchmark for success. The ability to deal with increasing protocol complexity requires investigators to be more adept at implementation and compliance to sustain their ability to conduct clinical trials.