Implementing rigorous standards for the professionalism of principal investigators (PIs) and clinical research coordinators (CRCs) at study sites will help everyone do a better job conducting clinical trials, says Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, chief implementation and operations officer and a member of the Quality Assurance and Compliance Committee at IACT Health.
The problem? “Few people know there are resources like this out there for them,” Senn notes, referring to how she was fresh off attending an Association of Clinical Research Professionals (ACRP) PI bootcamp session in Denver. She says PIs like herself are “excited when they hear about standards and competencies.”
However, PIs, CRCs, and others must take proactive steps to become part of the solution or they won’t have any chance to influence the ultimate programs, Senn adds. “They need to get involved to have input,” she says.
In late October, ACRP announced a new initiative to develop competence standards for PIs.
“ACRP is leading innovation in the clinical research workforce by setting standards for professional competence,” says ACRP Executive Director Jim Kremidas. “By focusing on the competence of the PIs who are ultimately accountable for clinical trial conduct, ACRP and its partners are taking a major step to promote excellence in clinical research.”
Senn is also a big fan of the work being done by the Joint Task Force (JTF) for Clinical Trial Competency. “I tell PIs that standards can help them see what sub-investigators are capable of,” she says. For example, can a PI safely delegate responsibility for documenting and reporting adverse events in a clinical trial? Is the sub-investigator qualified? It’s tough to tell without some form of meaningful standards and certifications in place, Senn notes.
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.
ACRP’s certification programs are harmonized with the Core Competency Framework developed by the JTF, whose contributors and collaborators include leading organizations representing clinical research sponsors, contract research organizations, study sites, and academia.
In addition, standards will help PIs and others better self-assess their levels of professionalism. “Standards can be used to help them identify what they don’t know, and find out how to learn it,” Senn says.
Author: Michael Causey