Focus Area: Clinical Trials & Research

The Clinical Research Glossary: Adoption, Implementation, and Impact

Biannual Meeting

Webinar

Presented on: June 16, 2026

How do leading organizations turn plain language from an aspiration into everyday practice? In this June 2026 MRCT Center webinar, three users of the Clinical Research Glossary share how they put it to work, from global pharma to grassroots patient advocacy.

The Clinical Research Glossary is a free, publicly available resource that translates complex clinical research terms into clear, plain-language definitions. It empowers patients, participants, and the public to make informed decisions about their care and research participation. Developed by the MRCT Center with a diverse, multi-interest-holder workgroup, its definitions have been part of the CDISC global data standards since 2023.

This session highlights real-world adoption and impact, followed by a panel discussion and audience Q&A.

Speakers

  • Anna Subrizi, Senior Director, Patient Empowerment, Bristol Myers Squibb. How the Glossary is embedded in BMS’s Universal Patient Language (UPL) program and used across teams for plain language summaries, informed consent forms, and patient materials.
  • Sudipta Chakraborty, PhD, Head, Health Literacy & Plain Language Center of Excellence, Biogen. How the Glossary became the exclusive reference for Biogen’s Plain Language Glossary 2.0 and anchors a cross-functional content reuse initiative.
  • R. Bernard Coley, Co-Chair, Special Interest Group – Black Diaspora; Care Partner and Research Advocate; recipient of the 2026 World Parkinson Coalition Robin A. Elliott Community Service Award. How the Glossary supports community education, including the Black Parkinson’s Disease Summit.

Moderator: Sylvia Baedorf Kassis, Program Director, MRCT Center

What’s covered

  • The MRCT Center and its ongoing commitment to health literacy
  • The Clinical Research Glossary and the collaboration with CDISC
  • The 2026 public review (June 12 to July 13): 27 definitions up for review, 24 new and 3 updated
  • Enterprise use cases from Bristol Myers Squibb and Biogen
  • Community and advocacy use cases in Parkinson’s disease education
  • Panel discussion and audience questions
Download the Slides
06-16-2026_MRCT_Biannual-Glossary-Meeting_June 2026Download

Public Review is a Critical Part of the Clinical Research Glossary process.

Part of being a CDISC global plain language standard means all new terms and definitions, plus change requests we received throughout the year, go through a public review process.

Public Review of the Clinical Research Glossary happens every June. Public Review is now open: June 12 – July 13, 2026

After definitions are developed by the Clinical Research Glossary team, Public Review ensures the definitions get an extra review by people who were not involved in the project. This helps us be more confident that the definitions are clear and easy to understand.

Help us spread the word about Public Review! Click here for the Media Kit.

Send us your feedback using the MRCT Center Public Review process.

  • The MRCT Center’s process uses a simple survey to collect feedback.
  • This process will not require reviewers to create an account, but we do ask for name, organization and email address. Collecting this information allows us to validate the entry and follow-up with each person to let them know how the comment was addressed.
  • You can send us feedback on already posted definitions all year round and suggest new words for us to consider whenever you want. Click here to contact us.

The CDISC Public Review process is also an option if you know how to use JIRA

  • CDISC’s Public Review process uses Wiki JIRA.
  • This works great if you already have a CDISC login and are familiar with the process. Individuals will need to create accounts to provide comments via JIRA.

CDISC has kindly provided video instructions here.

How to Submit Comments on Glossary Definitions via JIRA

Clinical Research Glossary
Clinical Research Glossary: Use Case Collection
For Patients and Participants

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

Follow the MRCT Center on LinkedIn
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center

Applied Health Literacy: Using Teach-Back in Conversations about Clinical Research
Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process
The Clinical Research Glossary: New Words, New Opportunities
A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration

Good Clinical Practice in Practice: Implementing ICH E6(R3)

Webinar

Date: May 22, 2026

On May 22, in recognition of Clinical Trials Week, MRCT Center Executive Director Sarah White convened the ICH E6(R3) Expert Working Group’s regulator and industry topic leads, Cheryl Grandinetti, U.S. FDA; David Nickerson, EMD Serono  and PhRMA ; and Rebecca Stanbrook, RESaltas GmbH and EFPIA , for “Good Clinical Practice in Practice: Implementing ICH E6(R3).” The panel walked through the guideline’s foundational concepts (Quality by Design, Quality Management, Critical to Quality Factors, and risk proportionality), grounded those concepts in a working case example using Risk-Based Quality Management principles, and discussed the practical challenges teams are encountering as they translate ICH E6(R3) into protocols, processes, and day-to-day oversight. The recording and slides are available here.

The webinar is part of the MRCT Center’s broader work as the training partner for the revised ICH E6(R3) Good Clinical Practice guideline. In collaboration with the ICH E6(R3) Expert Working Group, the MRCT Center has been developing a five-module course to help sponsors, investigators, and trial teams put the modernized guideline into practice. Module 1 (Introduction and Foundational Concepts) launched in October 2025, and Module 4 (Informed Consent) followed in January 2026. Module 3 (Data Governance) and Module 5 (Essential Records) are scheduled for release this summer, with Module 2 (Responsibilities and Oversight) to follow. The full course is available through the MRCT Center training library and the ICH Training Library.

YouTube: Clinical Research Competencies to Support Effective Patient Partner Engagement
2026-05-22 E6R3 webinar slides 22 MayDownload
2026-06-02_Clinical Trials Day Webinar_QA (2)Download

Data Quality, Model Validation, and Governance for AI Digital Twins and Synthetic Data

Webinar

Presented on: May 18, 2026

This webinar, the fourth in the MRCT Center’s AI Digital Twins and Synthetic Data series, focused on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. Panelists explored how to evaluate whether the models used are credible, whether the data underlying them are reliable and traceable, and whether the outputs can be verified and validated for use in regulatory and clinical decision-making. They also discussed what it means for a model to be “fit for purpose,” how definitional differences among these technologies shape regulatory review, and how clinicians, sponsors, reviewers, and regulators may use, interpret, and deploy these tools.

Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tina Morrison, VP, Scientific Strategy, EQTY Lab | Chao-Yi Wu, Assistant Professor of Neurology, Massachusetts General Hospital

Moderator: Barbara Bierer, Faculty Director, MRCT Center

2026-05-18b Data Quality Validation Governance DigiTwins and SynData_FINALDownload
Deploying Digital Twins and Synthetic Data in Evidence Generation
AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
AI Digital Twins and Synthetic Data: Application to Clinical Trials
Framework for Review of Clinical Research Involving AI
A Framework for AI Adoption and Oversight in Clinical Research

Clinical Research Competencies to Support Effective Patient Partner Engagement

Webinar

Date: May 7, 2026

The MRCT Center, CANTRAIN, and EUPATI hosted a webinar to unveil the results of the JTF-Patient Partner Project. This collaborative effort integrated patient and caregiver expertise directly into the JTF Framework, bringing together patient partners, academic researchers, study staff, industry representatives, and others to reimagine what patient partnership within clinical research teams should entail.

The proposed update includes a supplement focused on operationalizing patient partnership in clinical research. The results are both actionable and aspirational – a blueprint for building more skilled, inclusive, and equitable research teams that generate more responsive and impactful outcomes.

YouTube: Clinical Research Competencies to Support Effective Patient Partner Engagement
2026-05-07 JTF P3 Webinar SlidesDownload

Related Resources:

Good Clinical Practice in Practice: Implementing ICH E6(R3)

Webinar

May 22, 2026 @ 10:00 am – 11:00 am

ICH E6(R3) represents a major modernization of Good Clinical Practice since the original 1996 guideline, building on the risk-based and quality-focused principles introduced in E6(R2). It further emphasizes a proportionate, risk-based approach to trial design and conduct, incorporating Quality by Design and risk proportionality as foundational principles. The guideline expands expectations for data governance and clarifies sponsor and investigator responsibilities. However, guidelines alone do not drive change in practice; effective implementation depends on training and education.

As the ICH training partner selected to develop the ICH E6(R3) training curriculum, the MRCT Center, in collaboration with the ICH E6(R3) Expert Working Group, is producing a five-module course to translate the ICH document into actionable guidance for the people who run trials.

Clinical Trials Week honors trial participants and the workforce whose training and preparation shape their care. In that spirit, join Sarah White and a panel of experts representing the US FDA and industry sponsors, who are also members of the ICH E6(R3) Expert Working Group, to highlight the importance of implementing the ICH E6(R3) guideline correctly and discuss key areas of the ICH E6(R3) guideline that may be challenging to implement.

The session will walk through a practical case example applying Quality by Design principles, including the identification of Critical to Quality factors, and will explore implementation of ICH E6(R3) across key areas, such as data governance, sponsor and investigator responsibilities, and the incorporation of diverse perspectives in trial design and planning. The session will underscore the importance of all individuals performing clinical trial activities in understanding these critical study attributes and how their role contributes to safeguarding them and ensuring they are consistently protected through their day-to-day decisions and actions. It will also spotlight the available ICH E6(R3) training modules. Attendees will leave with an understanding of the foundational concepts in ICH E6(R3), how Quality by Design can be applied to clinical trial design and conduct, and how to introduce and disseminate the training to their teams.

October 29, 2022

Training & Education ›

The Clinical Research Glossary at Work: Adoption, Implementation, and Impact

June 16, 2026 @ 12:00 pm – 1:30 pm

virtual

The MRCT Center Clinical Research Glossary, a CDISC global standard since 2023, offers 216 plain-language definitions for clinical research terms used across the research enterprise.

Sylvia Baedorf Kassis, Program Director for the MRCT Center’s Health Literacy portfolio, will host a conversation with panelists from two sponsor organizations and a patient partner on how the glossary is being adopted, implemented, and used in practice.

Panelists include Anna Subrizi, Patient Empowerment Team Lead at Bristol Myers Squibb; Sudipta Chakraborty, who leads the Health Literacy Center of Excellence at Biogen; and Bernard Coley, a patient partner who applies the glossary in his Parkinson’s disease advocacy and education work.

The panel will cover how sponsors integrate the glossary across research and development, commercial, and patient-facing functions, as well as the business case for plain language and its impact within organizations and clinical research studies.

The MRCT Center will also share a preview of the new terms heading into a 30-day public review this June. Public review ensures that the glossary is a living, consensus-driven CDISC global standard. Each new definition is reviewed by researchers, sponsors, patients, and advocates before adoption, so the professionals who design trials have a trusted resource to communicate with participants and help enable informed decision-making. Attendees will learn what public review entails and how to submit feedback through the MRCT Center survey or the CDISC Wiki JIRA process.

Clinical Research Glossary

The Clinical Research Glossary: Learn More
The Clinical Research Glossary: Working Group
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center
On-Demand Webinar: The Clinical Research Glossary: New Words, New Opportunities
On-Demand Webinar: A Global Standard for Plain Language in Clinical Research: an MRCT Center and CDISC Collaboration

Data Quality, Model Validation, and Governance for AI Digital Twins and Synthetic Data

Webinar

May 18, 2026 @ 12:00 pm – 1:00 pm

Please join us on Monday, May 18, from 12:00 – 1:00 pm ET for the fourth webinar in the MRCT Center’s AI Digital Twins and Synthetic Data series. This webinar will focus on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. It will explore how to evaluate whether the models used are credible, whether the data underlying them are reliable and traceable, and whether the outputs can be verified and validated for use in regulatory and clinical decision-making. Panelists will discuss what it means for a model to be “fit for purpose,” how definitional differences among these technologies shape regulatory review, and how clinicians, sponsors, reviewers, and regulators may use, interpret, and deploy these tools. The session will include a moderated discussion and time for audience Q&A.

Deploying Digital Twins and Synthetic Data in Evidence Generation
AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
AI Digital Twins and Synthetic Data: Application to Clinical Trials
A Framework for AI Adoption and Oversight in Clinical Research
Framework for Review of Clinical Research Involving AI

Pregnancy Privacy Protections for Participants (P4) Tools

Toolkit

Released on: April 29, 2026

The MRCT Center has released the first three tools in the Pregnancy Privacy Protections for Participants (P4) Toolkit. These resources inform research teams, IRBs, and participants about data privacy risks if a participant becomes pregnant during a study.

Following the Dobbs decision, the changing landscape of reproductive rights in the U.S. has introduced new challenges for clinical trials, both for studies of pregnancy-related conditions and for any trial involving participants who could become pregnant. Because pregnancy testing and outcomes may be tracked during screening and throughout a trial, it is important to carefully consider how, and how well, clinical trial data can be protected, and how to communicate pregnancy privacy risks to potential and enrolled participants. These issues were explored in a MRCT Center Bioethics Collaborative forum,  “Impact of Dobbs on Reproductive Health: Unintended Consequences for and on Research” and in the recent NEJM Evidence paper “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.“

The three tools are:

The first two are directed toward clinical research teams and IRBs. The third is for research staff to adapt and share with participants; it is written in plain language and highlights terms defined in the MRCT Center’s Clinical Research Glossary. Each tool is a prototype; the introductory page instructs teams to revise content according to their specific study and local legislative and site context.

The work draws on MRCT Center efforts in the Impact of Privacy Laws, the Bioethics Collaborative, and Inclusion of Pregnant and Lactating Populations (within the Representation in Research portfolio).

We welcome your feedback as we develop additional tools to complete the P4 Toolkit.

MRCT Center Pregnancy Privacy Protections – Local ContextDownload
MRCT Center Pregnancy Privacy Protections – Recommended Language for ICFsDownload
MRCT Center Pregnancy Privacy Protections – Privacy ConsiderationsDownload
Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research

Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.

Clinical Research Competencies to Support Patient Partner Engagement

Webinar

May 7, 2026 @ 9:00 am – 10:00 am

Join the MRCT Center, CANTRAIN, and EUPATI to learn the results of an effort to integrate patient partnership into the existing Joint Task Force (JTF) Framework for Clinical Trial Competency.

The initiative, entitled “JTF-Patient Partner Project (P3) – Co-Creating Clinical Research Competencies to Support Effective Patient Partner Engagement Activities,” united a representative group of patient and caregiver partners, academic researchers and study staff, industry representatives, and others, to imagine what patient partnership within the JTF Framework would cover and include.

The updates proposed in JTF-P3 include a supplementary addendum focused on integrating patient partners into the study team. The results provide a blueprint that is both operational and aspirational, supporting more skilled, inclusive, and equitable clinical research teams to achieve results faster through more responsive and impactful trials.

By the end of this webinar, attendees should be able to:

  • Explain what patient partners and partnerships are, and why patient partner inclusion within study teams is so important
  • Explain the JTF-P3 process
  • Describe the JTF-P3 updates to the original JTF Framework
  • Identify next steps in the process of meaningful patient partner integration into study teams

This webinar will be offered twice, with the same content presented by different regional panelists. One registration and one Zoom link cover both sessions. Register once and join whichever session best fits your schedule.

  • Session A — May 7, 9:00 AM – 10:00 AM EDT (Boston/Ottawa); 3:00 PM – 4:00 PM CEST/SAST (Brussels/Cape Town); 6:30 PM – 7:30 PM IST (New Delhi)
  • Session B — May 7/8 8:00 PM – 9:00 PM EDT (Boston/Ottawa); 9:00 AM – 10:00 AM JST (Tokyo, May 8); 10:00 AM – 11:00 AM AEST (Melbourne, May 8)

Deploying Digital Twins and Synthetic Data in Evidence Generation

Webinar

Presented on: March 19, 2026

What does it take to deploy digital twins and synthetic data in clinical evidence generation — and what do regulators expect when you do?

In this third webinar in the MRCT Center’s Digital Twins and Synthetic Data series, a multidisciplinary panel examines the real-world application of these technologies across the clinical trial lifecycle. The discussion covers evidence quality and validation, regulatory benchmarks, model transparency, and the evolving landscape of FDA and EMA expectations. Panelists draw on experience spanning machine learning, FDA policy development, and drug development leadership to offer practical, grounded perspectives on what adoption looks like today — and where the field is headed.

Topics include:

  • Defining digital twins and synthetic data: key distinctions and appropriate uses
  • Reducing control arms and enhancing statistical power in randomized and single-arm trials
  • Applications across rare disease, oncology, and common conditions
  • Machine learning vs. traditional statistical approaches: complementary, not competing
  • Regulatory acceptance: FDA draft guidance, EMA qualification of PROCOVA, and engagement strategies
  • Model evaluation benchmarks and performance validation across development phases
  • Cultural and organizational barriers to adoption — and how to address them

Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tala Fakhouri, VP Consulting AI & Digital Policy and Real World Evidence, Parexel | Karen Smith, Board Director, Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics

Moderator: Barbara Bierer, Faculty Director, MRCT Center

A Framework for AI Adoption and Oversight in Clinical Research
2026-03-19b Evidence Generation DigiTwins and SynData_FINALDownload
AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
AI Digital Twins and Synthetic Data: Application to Clinical Trials
Framework for Review of Clinical Research Involving AI
A Framework for AI Adoption and Oversight in Clinical Research