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 inBMC 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.”

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

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

MRCT Center Annual Meeting

December 4, 2013 @ 7:30 am 5:00 pm

Loeb House at Harvard University, Cambridge, MA

The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.

For more information please see the links below. 

2013-12-04 MRCT Center Annual Meeting Agenda

2013-12-04 MRCT Center Annual Meeting Proceedings

Deliverables

MRCT Center Annual Meeting

December 3, 2014 @ 7:30 am 4:00 pm

Loeb House at Harvard University, Cambridge, MA

The Harvard MRCT Annual Meeting 2014 focused on the Guidance Document and Toolkit that the Harvard MRCT workgroup developed for returning aggregate results to study participants and included a panel with various stakeholder perspectives on returning of results. In addition, Harvard MRCT co-directors introduced their work of addressing regulatory, trial causality and compensation issues in India.

For more information please see links below.

2014-11-26– MRCT Annual Meeting Agenda

2014-12-03 MRCT Annual Meeting Slides

2014-12-03 MRCT Annual Meeting Proceedings

Deliverables

Projects

Global Simultaneous Drug Development Workshop, Beijing

May 21, 2016 @ 8:00 am 5:00 pm

Bejing, China

To facilitate discussion on acceleration of simultaneous drug development around the world, Beijing Biometrics Association (BBA) – Beijing Biometrics Forum (BBF) organized this joint symposium on recent advances in the design and conduct Multi-Regional Clinical Trials (MRCTs).

For more information, please click below.

2016-04-28 China MRCT workshop_Final

Deliverables

Projects

Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of a Framework

October 19, 2016 @ 8:00 am 4:00 pm

Harvard Faculty Club, Cambridge, MA

The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences.

Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.

This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.

For registration, please click here.

October 19 Workshop Agenda

Proceedings from Core Competencies Workshop

Deliverables

ICH GCP Pilot Training

October 17, 2017 @ 8:30 am 5:00 pm

Harvard Faculty Club, Cambridge, MA

Pilot Training on International Conference on Harmonisation Good Clinical Practice (ICH GCP): The MRCT Center is hosting a 3-day training for international regulators and professionals on ICH GCP.

Deliverables

Projects