Harmonized Core Competency Framework
Draft Version 2.0

The Joint Task Force for Clinical Trial Competency (JTF) invites public comment on the Draft Version 2.0 of the Harmonized Core Competency Framework. The decision to update the Framework is indicative of the JTF’s commitment to meeting the needs of clinical researchers globally. More than that, the decision recognizes the diversity of experiences across the clinical research community.


REVIEW
DRAFT VERSION 2.0

 

 

 

The time frame for submitting comments has passed.


 

About Version 2.0 and the Revisions Workgroup


The Joint Task Force for Clinical Trial Competency (JTF) decided in November 2016 to update the Harmonized Core Competency Framework. This decision followed on the October 2016 Core Competencies in Clinical Research Workshop, which brought together users of the Framework from across the globe. The daylong workshop featured case studies by these users, who highlighted their own innovative applications of the Framework and suggested possible revisions to it, based on their experiences.

To accomplish this task, the JTF organized the Revisions Workgroup, a multi-stakeholder group of representatives from across the clinical research community. The group comprised JTF members, workshop participants, and other interested stakeholders. It was central to the Revision’s Workgroup to have a widely representative workgroup, including members from all parts of the global research community (e.g., academic sites, professional societies, industry, CROs).

The Revisions Workgroup was led by Terri Hinkley (Association of Clinical Research Professionals), Rebecca Li (Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard), and Stephen Sonstein (Eastern Michigan University; Consortium of Academic Programs in Clinical Research).

The Revisions Workgroup evaluated revisions suggested at the workshop and solicited further recommendations and comments from stakeholders and utilizers. In order to evaluate these suggested revisions, the Revisions Workgroup developed a rubric to gauge its impact, relevancy, necessity, and applicability across the clinical research community.

The Workgroup separated into 3 sub-groups in order to evaluate suggested revisions to the competency domains. These recommendations were then collected, and a draft of the newly updated Framework was distributed to the Revisions Workgroup and the JTF for further review

These comments were incorporated into this Final Draft of the Harmonized Core Competency Framework, Version 2.0.

 

 

Revisions Workgroup

Leadership

Terri Hinkley, Association of Clinical Research Professionals (ACRP)
Rebecca Li, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
Stephen Sonstein, Eastern Michigan University; Consortium of Academic Programs in Clinical Research (CoAPCR)

Members

Carmen Aldinger, MRCT Center
Liza Behrens, Rockefeller University
Barbara Bierer, MRCT Center
Joan Butler, George Washington University
Jill Chapman, ACRP
Matilde Damian, APEIC
Robin Douglas, Quintiles IMS
Patricia Eckardt, Rockefeller University
Catherine Griffith, Massachusetts General Hospital
Carolynn Thomas Jones, The Ohio State University
Christopher Kabacinski, MRCT Center
Rosemary Keller, Recro Pharma
Jared Kerr, University of North Carolina — Wilmington
Ian Kerridge, Praxis Australia
Rita Lennon, Pima Community College
Lisa Marsh, Baylor Scott & White Health
Cathleen McManamon, AstraZeneca
Melissa Nezos, Chiltern
Regina Ponder, Clinical Research Consultant
Lesley Robson, Cancer Research UK
Lawrence Stern, Merck
Nicole Tesar, Harmony Clinical Consulting
Arminda Valles-Hall, ARCRP
Jose Luis Viramontes-Madrid, PPD
Michelle Wartak, Broad Institute of MIT and Harvard
Liz Wool, Barnett International, Inc.