A New Model to Support Leadership Skills of Principal Investigators


With the intention of minimizing the risks in clinical trials, we took a closer look at the skills expected from the Principal Investigator (PI). In addition to the expected technical skills, we analysed the soft skills and the useful results they bring to the system and to the different actors. We conclude that non-technical skills of the PI are to be considered to minimize protocol-related risks, increase performance and well-being in organizations managing clinical research.

We propose a PI Leadership model that aligns accountabilities and competencies ( skills and behaviours)  with expected  outcomes (table I) which meet  the GCP standards. The model includes the four key roles of the Investigator: Leader, Physician, Researcher and Study Manager.