ACRP Releases Final Core Competency Framework for Clinical Study Monitoring

Core Competency Framework for Clinical Study Monitoring

The Association of Clinical Research Professionals (ACRP) today announces availability of the final Core Competency Framework for Clinical Study Monitoring.

The framework identifies the core competencies required of individuals involved in clinical study monitoring and is the first product of the cross-industry ACRP Workforce Development Task Force and Steering Committee, whose members include representation from leading stakeholders in the clinical research enterprise, including Advanced Clinical, AstraZeneca, Cancer Research UK, and Merck, among others.

The ACRP Core Competency Framework for Clinical Study Monitoring can be downloaded at

The framework comes as the clinical research enterprise faces a major shortage of clinical research associates/monitors (CRAs) in the workforce.

“Today’s announcement is a major milestone in ACRP’s efforts to collaboratively professionalize clinical research by setting the standards for professional competence,” says Terri Hinkley, RN, BScN, MBA, CCRC, FACRP, Workforce Innovation Officer at ACRP. “Monitoring, as an activity, is undergoing significant change, and new roles intended to support monitoring activities are emerging. This landmark document now provides professionals and employers with clearly defined, collaboratively developed expectations for monitoring conduct at a time when our industry needs it most.”

“Member of our Steering Committee are now driving these competencies as standards within their companies. We look forward to working with any groups interested in implementing these standards at their organizations,” says Jim Kremidas, ACRP Executive Director. “The Core Competency Framework for Clinical Study Monitoring will impact change and support the growth and development of the clinical research workforce.”

The Core Competency Framework for Clinical Study Monitoring is the first core competency framework aligned to the eight core competence domains for clinical research professionals, as defined by the Joint Task Force for Clinical Trial Competence.

“The framework is intended to define the competencies of all individuals involved in the function of clinical study monitoring,” says Hinkley. “Given the relatively new promotion and adoption of risk-based monitoring principles and practices, ACRP will monitor the industry landscape to assess how the industry is implementing these principles within their organizations, and will update the framework as needed to ensure it is accurately representing practice.”

ACRP will now begin work to define the requirements for an Entry-Level Assessment (ELA) of clinical researchers and competencies for site personnel. ACRP is actively seeking stakeholder organizations to participate in the design of the ELA. Interested parties are encourage to contact Hinkley at

Jeremy Glunt
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