The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators, and clinical research professionals that has developed a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Chinese.
The JTF Core Competency Framework is made up of 8 Competency Domains, which are broad categories of knowledge, skills, and attitudes necessary for conducting clinical research.
Each Domain contains specific competency statements expressed at a Fundamental, Skilled, and Advanced level.
Fundamental: Can perform the task and/or exhibit the knowledge at an essential or fundamental level; may require some coaching or supervision.
Skilled: Can perform tasks or skills independently, consistently, and accurately and has a moderate level of expertise. Efficient and high-quality work; able to independently navigate resources and use tools well.
Advanced: Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem-solving.
The JTF Core Competency Framework (JTF) has been utilized widely and internationally by academic institutions, corporate entities, and professional societies to improve the quality, accuracy, and safety of clinical research. The JTF has compiled a listing of representative publications, presentations, and weblinks to provide examples and references for those entities wishing to utilize the framework to meet their own needs.
Click here to learn more about how to use the JTF Framework.
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
The document was endorsed by 36 signatories, including patient advocacy groups and professional associations. This document is currently available for public comment on the FDA website, and we encourage you to comment.
The Joint Task Force (JTF) for Clinical Trial Competency has updated and released its Core Competency Framework Version 2.0 for use by clinical research professionals and staff worldwide.
The JTF has always recognized that the dynamic nature of the clinical research enterprise will necessitate the continuing revision of the Framework so that it meets the latest scientific, ethical and research challenges of clinical researchers.
In October 2016, the MRCT Center hosted the Core Competencies in Clinical Research Workshop, which brought together the JTF, a diverse group of representatives from the clinical research community, and stakeholders who have utilized the Framework in their own organizations. Case studies were presented to highlight real-world applications, to gather feedback on potential revisions, and to develop future objectives for the JTF. Following this Workshop, the JTF launched the Revisions Workgroup to evaluate changes to the Framework based on suggestions from implementers and stakeholders. The Revisions Workgroup evaluated suggested revisions against a rubric that measured impact, and relevance across the clinical research community, global applicability, and necessity.
The revised Core Competency Framework Version 2.0, which resulted from this process, was released on September 1, 2017.
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .
This framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. An international multi-stakeholder workgroup, convened by the MRCT Center, developed this framework.
The foundation of this framework is summarized in 12 principles
In particular, the updates focused on restructuring the content for plain language summaries and the template for returning aggregate results to correspond with the structure and headings that will be required by the EU guidelines. In addition, we updated terminology by adding “aggregate” to the title of the document and referring to Plain Language Summaries rather than research results summaries. We also added additional health literacy resources and links to external resources.
The MRCT Center Individual Return of Results workgroup developed principles that are directly relevant to the return of individual research results to research participants. These principles are summarized in a brief Principles Document.
On December 7, 2016, at the MRCT Center Annual Meeting, we released Version 1.0 of the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines – Guidance Document.
A multi-stakeholder workgroup, convened by the MRCT Center, developed this document, which outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial.
A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.
Please see the Return of Individual Results: Principles and Approach document and send comments to MRCT@bwh.harvard.edu by September 1, 2016 with the subject line IRR Principles.
The period for receiving comments is now closed.
Read more about the MRCT Center’s work in returning individual results to participants.
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
These documents have been revised, and the latest versions are now available:
The Post-Trial Responsibilities Working Group, sponsored by the MRCT Center at Harvard, was launched in February 2015 and is a multi-stakeholder group with 55 members from academia, industry, non-profit organizations, government, and patient organizations. Twelve countries are represented.
The purpose of this working group is to develop an ethical framework for post-trial responsibilities, including case studies and practical guidance, which can then be used to conduct training sessions.
As an initial step, the working group focused on a single consensus definition of post-trial responsibilities and related terminology – post-trial access to an investigational drug, and expanded access of an investigational drug. These definitions will serve as the platform upon which the framework will be based. The consensus definitions as of March 2015 can be accessed below.
