About this Work

In 2020, the MRCT Center launched a pilot project to develop a plain language clinical research glossary, convening a committed workgroup of patient advocates and other representatives from across the clinical research industry. The resulting work is reflected here on this website with clear, understandable definitions and additional supportive information to foster learning and exploration being freely available for anyone to use.

After significant user interest and enthusiasm, the work of expanding the MRCT Center Clinical Research Glossary began in 2022. In collaboration with new and former volunteers, the workgroup has been dedicated to growing this important resource for patients, participants, and caregivers, as well as the research professionals who want to communicate with the public in more understandable ways.

Today the work continues, in collaboration with CDISC**, to grow and maintain this resource as one of CDISC’s global clinical research standards.

The Clinical Research Glossary Pilot: Approach

  1. Select and define words.
  2. Collect written feedback from the multi-stakeholder Development Team on plain language definitions.
  3. Hold consensus conversations with Development Team.
  4. Send definitions to the patient/caregiver Review Team for written feedback and consensus conversations.
  5. Finalize plain language definitions.
  6. NEW CDISC public review process*** of plain language definitions. Click here to learn more about how to submit comments for public review.
  7. Additional supportive content developed and all information finalized for release
    •  MRCT Center – all content on this website
    • CDISC – plain language definitions and links to the MRCT Center Clinical Research Glossary.

Learn more about how this work is done here:

Baedorf Kassis S, White S, & Bierer B. (2022). Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research communityJournal of Clinical and Translational Science, 1-20. doi:10.1017/cts.2022.12

**More 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.

***More about the CDISC public review process:

CDISC offers a quarterly public review period, a time when feedback on its new standards can be collected from its users.  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.

Workgroup Members

Workgroup Members

The MRCT Center is grateful for the workgroup’s contributions and participation in this pilot project. The Clinical Research Glossary project was lead by MRCT Center Program Manager, Sylvia Baedorf Kassis, MPH and Faculty Director, Barbara Bierer, MD.

Name Organization
Behtash Bahador CISCRP
Sarah Balay Privacy Analytics/PhUSE
Stephen Carr Janssen
Jessica Chaikof Patient Advocate
Lisa Chamberlain James Trilogy Writing and Consulting
Deborah Collyar PAIR/Patient Advocate
Jean-Marc Ferran Qualiance ApS/PhUSE
Helle Gawrylewski CDISC Glossary Lead/Hawkwood Consulting LLC
Art Gertel MedSciCom, LLC
Shannon Hamill Patient Advocate
Lauren Hamill Patient Advocate
Julie Holtzople Astra Zeneca
Lukasz Kniola Biogen/PhUSE
Marilyn Neault Patient Advocate
Elyssa Ott Janssen
Brandis Pickard CISCRP
Robyn Rennick GlaxoSmithKline
Marian Ryan Institute for Healthcare Advancement
T.J. Sharpe Medidata/Patient Advocate
Kamila Sroka-Saidi Boehringer Ingelheim
Mary Stober Murray National Minority Quality Forum
Gloria Stone G Stone Connections
Michele Teufel Astra Zeneca
Desiree A.H. Walker Patient Advocate
Robert Weker Patient Advocate

Glossary Workgroup Members By Group

Marilyn Neault and Desiree Walker

Development Team

Behtash Bahador, CISCRP

Rebeccca Baker, CDISC

Lisa Chamberlain James, Trilogy Writing

R Bernard Coley, Advocate

Deborah Collyar, PAIR/Advocate

Scott Finger, CISCRP

Helle Gawrylewski, Hawkwood Consulting, LLC

Art Gertel, MedSciCom, LLC

Monica Helton, Eli Lilly

Julia Hild, Boehringer-Ingelheim

Maureen Kashuba, Merck & Co.

Kevin Kwok, Advocate

Rena Lubker, Medical University of South Carolina

Keri McDonough, Syneos

Alice Miller, Syneos

Erin Muhlbradt, NCI Enterprise Vocabulary Services/CDISC

Robyn Rennick, GlaxoSmithKline

Harold Silverman, argenx

Gloria Stone, G Stone Connections

Cornelia Weiss-Haljiti, Boehringer-Ingelheim


Review Team:

Roberta Albany, Advocate

Jessica Chaikof, Advocate

Talia Cohavi, Advocate

Maura Cummings, Advocate

Anne Marie Mercurio, Advocate

Kimberly Richardson, Advocate

TJ Sharpe, Advocate

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