The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
Topic: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues (continued). This is the continuation of a discussion first introduced at the April 9, 2026 R3 meeting.
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.
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.
Join us on June 22, 2026, 9:00-11:00 AM ET for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting. This meeting will focus on two recent proposed revisions to the JTF Framework: the JTF-Patient Partner Project and an update to Domain 6. We will hear about the proposed updates, discuss them with users of the JTF Framework, and gather input on any further updates needed.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
Topic: What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
