Comments provided to: NIH National Library of Medicine
Description: The MRCT Center submitted a public comment in response to the NIH National Library of Medicine’s request for information, “Future Directions for the NLM Information Resource Grants (G08) Program.” The comment affirms strong support for NLM’s mission and the trustworthy resources it offers through PubMed, ClinicalTrials.gov, GenBank, and MedlinePlus, and proposes several ways to expand the G08 program with a focus on clinical trials and research. It recommends deploying libraries and librarians as trusted access points that help the public find and interpret research information; extending these resources to rural and historically underserved areas as entry points for digital trial methods and study recruitment; improving the utility of ClinicalTrials.gov through electronic health record integration for point-of-care trial matching, more complete eligibility criteria, plain-language trial summaries, and machine-readable protocol templates; and providing educational resources on the responsible and practical use of AI technologies. The comment urges NLM to foster an AI-ready research information ecosystem grounded in data interoperability standards, computable metadata, benchmark datasets, FAIR research outputs, and systems that protect personal health information.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
This recording is from the JTF Biannual Global Meeting held June 22, 2026. The meeting focused on two recent proposed revisions to the JTF Framework: the JTF-Patient Partner Project (P3) and an update to Domain 6. Speakers presented the proposed updates, discussed them with users of the JTF Framework, and gathered input on further changes needed as the Framework moves toward Version 4.0.
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
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
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.
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.
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
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.
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.
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.
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.
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 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.
