Project Plan

The work of the Joint Task Force for Clinical Trial Competency (JTF) is based in the concept that competency is essential for the safe, ethical and rigorous conduct of clinical trials.

Since publication of the Framework, numerous institutions have instituted competency-based education in order to train their workforce, develop qualification standards, and lead career development. The JTF was formed to bring together these high-quality efforts and to develop a single set of harmonized core competency statements for all clinical research professionals.

The JTF engaged in a three-step process to distill the competencies:

1.  Identify competency domains, which are broad areas of knowledge, skills, and attitudes that are essential for successfully conducting clinical research.

2. Map, harmonize, and define competencies after reviewing resources from institutions across the clinical research enterprise. Competency statements were extracted from each training resource and mapped into appropriate domains. From there, the JTF aligned similar statements into a single, harmonized competency statement. The product was the Harmonized Core Competency Framework for Clinical Research Professionals, comprising 51 competencies in 8 domains.

3. Obtain endorsement from contributors and stakeholders involved in clinical research.

The JTF intends to develop the Core Competency Framework to meet the needs of clinical researchers as the discipline evolves. The October 2016 workshop, “Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework,” provided the JTF with an opportunity to establish a plan for revising the Framework and for developing additional resources for clinical researches.

Phase I: 2017

Revising the Framework, Leveling the Competencies

Phase II: 2018

Developing Competency Portfolios, Metrics, and Quality Standards

Phase III:2019

Translation of Framework into multiple languages to facilitate global integration

Update of Framework to include competencies related to clinical project management and technology related enhancements to the clinical research enterprise.

Phase IV: 2020

International self-assessment survey of clinical research competency

Additional translations

Phase V: 2021

Framework update and revision