Focus Area: Capacity Building

Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

Publication

Published on: January 5, 2022

Published in: Therapeutic Innovation & Regulatory Science

In 2014, the Joint Task Force for Clinical Trial Competency (JTF) published its Core Competency Framework. The Framework has been utilized internationally by academic institutions, corporate entities, professional associations, educational and training programs, and regulatory agencies and integrated into their activities. The JTF has continually updated and expanded the scope of the Framework to reflect changes in the scientific understanding and methodology utilized in conducting clinical research. In 2019, representatives from the Drug Information Association Professional Development and Project Management Leadership Communities approached the JTF reflecting the importance of clinical project managers and the project management skill set to the clinical research enterprise. In response, the JTF created a Project Management Competency Task Force to define and document these core competencies with recommendations for their inclusion as a revision to the Framework 3.0. Two new specific competencies with related examples were incorporated into Revision 3.1 and expressed at the Basic, Skilled and Advanced levels. In addition, the wording of several existing competencies was modified, and related examples added to reflect the knowledge, skills, and attitudes of clinical project managers.

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The MRCT Center Glossary As A Global Standard For Plain Language: Announcing A Collaboration With CDISC

Clinical research is essential for the discovery of new treatments and medical interventions that advance public health and medicine. Yet clinical research is complex, and scientific concepts are often complicated to explain. Several organizations have developed health- and disease-specific glossaries, which are often technical or intended for scientific stakeholders. Even glossaries developed for the general public are more focused on medicine and health, not research.

As a result, the MRCT Center developed a comprehensive and publicly available plain language glossary of clinical research terms and procedures—built collaboratively with patients, caregivers, and other clinical research industry stakeholders. Today we announce a collaboration between the MRCT Center and CDISC to sustain and expand the potential of this resource to provide standardized and harmonized plain language options for the technical language that is often used in participant-facing documents and materials.

Dr. Barbara Bierer, MRCT Center Faculty Director, enthusiastically endorsed the partnership. “Expanding access to the MRCT Center’s plain language glossary will advance health literacy, giving patients and their caregivers the resources they need to make informed decisions about their participation in clinical research.”

“Clear communication is essential to the success of research and the development of new treatments and therapies that people need,” said Rhonda Facile, VP, Partnerships and Business Development, CDISC. “CDISC is pleased to collaborate with the MRCT Center on this important initiative to advance health literacy.”

The resource will be governed via the robust CDISC Standards Development Process that invites input from the public broadly, expanded and sustained through the MRCT Center patient-centered consensus process, maintained and made freely available by both organizations working together to ensure the content’s quality. The plain language definitions developed for the MRCT Center Clinical Research Glossary will be included as a CDISC standard starting in 2023, and as such, will go through a public review process.  Click here to complete the March 2023 public review.

Please join the MRCT Center team for a webinar on April 5, 2023 from 11 AM – 12 PM EDT. Click here to register.

About CDISC

Clinical Data Interchange Standards Consortium is a non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.

Developing and Implementing a Self-Monitoring Toolkit For a Coordinated Multinational Randomized Acupuncture Trial

Tools

Published on: June 17, 2022

Published in: BMC Complementary Medicine and Therapies

Sylvia Baedorf Kassis, Sarah A. White, Barbara E. Bierer and others co-authored “Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial,” published in BMC Complementary Medicine and Therapies, which describes a self-monitoring toolkit that was developed and implemented in a coordinated multinational trial that involved sites in China, South Korea, and the U.S. Authors conclude that such a tool “provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities.”

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Standardizing and Measuring Principal Investigator and Site Qualifications for Conducting Clinical Trials Workshop

September 18, 2012 @ 8:00 am – 4:00 pm

Harvard Faculty Club, Cambridge, MA

The objective of this workshop was to agree on a consensus list of “key selection standards or criteria for sites and Principal Investigators,” to propose methods to quantify the importance of these criteria, and to make recommendations for the MRCT Center’s role moving these issues forward

For more information please see the links below. 

2012-09-18 Principle Investigator Workshop Proceedings

2012-09-18 Principle Investigator Workshop Agenda

Deliverables

Projects

MRCT Center Annual Meeting

November 28, 2012 @ 8:00 am – 4:30 pm

Harvard Faculty Club, Cambridge, MA

The objective of this meeting was to provide an update to all stakeholders regarding current initiatives and progress, engage regulators in the MRCT Center initiatives and mission, obtain feedback from regulators and stakeholders on MRCT Center’s ongoing and planned initiatives, and discuss the 2013 Budget and Proposed Goals.

For more information please see the links below. 

2012-11-28 MRCT Center Annual Meeting Agenda

2012-11-28 MRCT Center Annual Meeting Slides

2012-12-17 MRCT Center Annual Meeting Proceedings

Deliverables

Projects