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. 

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, which aims to revise the Harmonized Core Competency Framework by December 2017.

Leveling Workgroup, which aims to determine competencies for 5 roles in clinical research by December 2017.

September 1, 2017: Version 2.0 of Core Competency Framework for Clinical Research Professionals released