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
- Select and define words.
- Collect written feedback from the multi-stakeholder Development Team on plain language definitions.
- Hold consensus conversations with Development Team.
- Send definitions to the patient/caregiver Review Team for written feedback and consensus conversations.
- Finalize plain language definitions.
- NEW CDISC public review process*** of plain language definitions. Click here to learn more about how to submit comments for public review.
- 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 community. Journal 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.
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.
|Sarah Balay||Privacy Analytics/PhUSE|
|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|
|Marilyn Neault||Patient Advocate|
|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
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
Roberta Albany, Advocate
Jessica Chaikof, Advocate
Talia Cohavi, Advocate
Maura Cummings, Advocate
Anne Marie Mercurio, Advocate
Kimberly Richardson, Advocate
TJ Sharpe, Advocate