“All things begin and end with the investigator,” says Edwina McNeill-Simaan, MSHS, CCRP, CCRC, a clinical and translational research coordinator in obstetrics and gynecology at Vanderbilt University Medical Center.
However, that doesn’t mean principal investigators (PIs) always know what’s expected of them. Far from it, in fact. “They’re expected to hit the ground running,” McNeill-Simaan says, but many simply aren’t even ready to walk as a PI.
A member of the 2018 ACRP Training and Development Committee with a long history of working with both experienced and new investigators, McNeill-Simaan finds the relatively greener ones sometimes have no real understanding of their role and responsibilities. “I [often] have to walk them through” some of the process of conducting a clinical trial, she says.
Many doctors struggle from the very outset of the PI experience, McNeill-Simaan says. “They’ve got so much offloaded onto them, and the expectations are so high the moment they start their project,” she explains.
New PIs can also fall into another trap—namely, thinking they know more than they do. “They get a lot of information in residency and medical school,” she explains, “but sometimes they aren’t prepared” to take on the role of being a PI. It’s one of many factors contributing to the so-called “one and done” phenomenon, where a doctor will take on a PI role, find it confusing and frustrating, and decide to never try it again.
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.
“If they have infrastructure and staff well versed in the different areas of research and the dynamics of the project, great, but not everyone really has that,” McNeill-Simaan says.
Standards and certifications can help to address the knowledge gap, she says. “Taking yourself through the paces of learning the regulations and becoming certified, I think, is an excellent tool,” McNeill-Simaan notes. “I think it’s fantastic. It really shows your passion and enthusiasm for research, because you’re willing to take that step to make sure that others can recognize that you are ready to be a PI on a project.”
Author: Michael Causey