History

January 2013

The Joint Task Force for Clinical Trial Competency (JTF) was formed and the first face-to-face meeting was hosted by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) bringing together representatives from academic institutions, pharmaceutical companies, contract research organizations (CROs), clinical research sites, and professional societies.

The JTF established the goal of creating a universally applicable, globally relevant competency framework for the clinical research enterprise.

Spring and Summer 2013

Regular meetings of the JTF were held, including in-person meetings at the MAGI Conference (May) and DIA Conference (June).

October 2013

The JTF presented a report at the DIA Conference.

Spring 2014

Harmonized Core Competency Framework for the Clinical Research Professional was published simultaneously in CenterWatch White Papers, Clinical Researcher, and Journal of Clinical Research Best Practices.

2014 – 2016

Clinical research institutions worldwide utilized the Framework to develop job descriptions, training modules, and other resources.

Summer, 2016

MRCT Center assumes sponsoring and leadership role for JTF.

October 2016

Workshop on the JTF Harmonized Competency Framework—“Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework”—hosted by the MRCT Center at Harvard University, Cambridge, MA. The workshop brought together clinical researchers from across the globe to discuss applications of the Framework, present real-life case studies, and collaborate on the evolution and revision of the Framework.

November 2016

Two new workgroups were launched:

– Revisions Workgroup: to remove redundancies and rephrase wording to clarify Core Competency Framework.

– Leveling Workgroup: to define the core competencies at the Basic, Skilled and Advanced levels with appropriate examples.

May 2017

Clinicaltrialcompetency.org website posted.

September 1, 2017

Revisions Workgroup released Version 2.0 of Core Competency Framework for Clinical Research Professionals.

October, 2018

Leveling Workgroup published “Leveling the Joint Task Force Competencies for Clinical Research Professionals” in Therapeutic Innovation and Regulatory Science.  Version 3.0 of Core Competency Framework.

February, 2019

Launched https://mrctcenter.org/clinical-trial-competency website.

Launched workgroup for Clinical Project Management (CPM)

February, 2020

JTF-CPM workgroup released Version 3.1 of the Core Competency Framework which includes competencies relating to clinical project management and technology-related enhancements of the clinical research enterprise.

September – December, 2020

Global survey of self-assessed competency of clinical research professionals