It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in clinical trials; they’ve taken on the role of PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.
A Competency-Based Approach to Principal Investigator Responsibilities
Join us in Nashville, April 12-15, 2019 for this innovative new workshop during ACRP 2019. Attendees will leave better able to describe the core elements of key regulatory guidance documents as they relate to the roles and responsibilities of the PI; list the expectations that regulatory agencies and sponsors have for PI oversight of clinical trial conduct and examine whether given situations fulfill these expectations; and explain the role, value, and purpose of competency guidelines and how they can be used to better facilitate the appropriate delegation of responsibilities to other staff.