The complexity of current informed consent models limit, rather than support, patient comprehension. Informed consent forms (ICFs) often reach dozens of pages long, exceed the general reading levels of clinical trial participants, and are focused on regulatory compliance and liability concerns rather than participant understanding of their rights and options as clinical trial participants.
The MRCT Center seeks to reimagine informed consent processes, moving beyond compliance-focused documentation toward innovative, participant-centered approaches. This initiative is exploring disruptive solutions within the informed consent development timeline, from structural changes to pre-IRB approval innovations to post-IRB approval, personalized consent pathways that adapt a “fit-for-purpose” consent model.
Our goal is to fully re-envision the informed consent process with global partnerships, while respecting participant autonomy throughout the research process. This work will develop in parallel project workstreams dedicated to structural changes to the ICF, as well as to changes in content and process. To learn more or get involved, please email Blythe Chen.
OBJECTIVES
Scope current field of informed consent and identify strategies for improvement
Develop and validate models of new informed consent processes, incorporating new technologies
Develop multi-stakeholder consensus on improved informed consent processes in multi-national academic and industry clinical trials, aligned with regulatory and ethical expectations.
Create tools and resources to enable adoption of innovative informed consent approaches.
KeY MILESTONES
March 2026: Project launch
September 2025-March 2026: Convened the subject matter experts to scope the opportunities for reinventing informed consent processes in clinical trials.
October 2025: Organized an interactive brainstorming session during the MRCT Center’s Annual Symposium on the Reimagining the informed Consent Process, beginning the project workstream.
project Leadership & sTAFF
Barbara Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center
Blythe Chen, MPH, Research Assistant II, MRCT Center
From Policy to Practice: Implementing the EHDS for Responsible Data Sharing
The European Health Data Space (EHDS) establishes a common framework for sharing electronic health data across all 27 EU member states in a secure, standardized manner, advancing individuals’ ability to access and control their own health data and enabling certain health data to be used for approved secondary uses.
In May 2022, the European Commission proposed EHDS to harmonize electronic health data sharing and governance across all EU member states. The EHDS Regulation, finalized and entered into force for implementation on March 26, 2025, is the inaugural initiative among nine planned European sector-specific data spaces. As a new regulatory framework, EHDS introduces significant opportunities that encompass two core components: (1) patient rights regarding access and control of their electronic health data, supported by the necessary infrastructure; (2) provisions for access and secondary use of health data for research, innovation, policy development, and other approved uses. The implementation of these components requires harmonization of data governance mechanisms across diverse health systems of EU member states.
To support stakeholders in understanding and navigating this evolving landscape, the MRCT Center has partnered with Vivli to co-host a series of online, invitation-only forums for interested pharmaceutical and biotechnology companies.
These forward-looking sessions address and discuss EHDS implementation and its accompanying data governance, harmonization, and compliance pieces for secondary use of data, as well as allow for collaboration opportunities to develop and submit public commentaries on EHDS draft implementation guidelines. Through this collaborative approach, we aim to identify and address opportunities and challenges, ensuring EHDS fulfills its promise of advancing personal health, innovation, and clinical research across Europe.
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and Amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA Relevance). 11 Feb. 2025, http://data.europa.eu/eli/reg/2025/327/oj/eng.
Convene and engage global stakeholders to collaborate on EHDS developments, coordinate efforts, and foster dialogue on data sharing and governance.
Guide policy and framework development toward a harmonized system for secondary use of health data, ensuring alignment with ethical, regulatory, and compliance standards that advance innovation in clinical research and healthcare.
KeY MILESTONES
November 2025: Hosted the EHDS workgroup forum to review TEHDAS2 guidance and stakeholder insights, and submitted three comments to the second wave of TEHDAS2 Public Consultations, on draft guidelines addressing data minimization, opt-out implementation, and notification of significant findings.
September 2025: Hosted two EHDS workgroup forums, first featuring Elina Drakvik (Sitra), presenting EHDS rules for secondary data use, Finland’s implementation efforts, and ongoing work of the TEHDAS2 draft guidelines. The second forum, members prioritized and strategized on the TEHDAS2 draft guidelines for comment submission.
July 2025:Held the EHDS Workgroup forum, where Aneta Tyszkiewicz, Associate Director, Digital & Data for the Science Policy and Regulatory Affairs team at EFPIA, provided an overview of the EHDS regulation and EFPIA’s active engagement in this area.
May 2025:The EHDS Workgroup Forum convened industry members to discuss the practical implications of EHDS for industry and research organizations and how to transform uncertainty into actionable, pragmatic next steps.
March 2025:Launch of Workgroup Webinar Series “From Policy to Practice: Implementing the EHDS for Responsible Data Sharing.” The forum convened experts from industry, legal, and regulatory backgrounds to discuss the European Health Data Space (EHDS) and its implications for the sharing of clinical trial data.
project Leadership & sTAFF
Barbara E. Bierer, MD, Faculty Director, MRCT Center
Liz Graham, MPH, MS, Senior Clinical Research Data Manager, Vivli
Lisa Koppelman, MSW, LICSW, MPH,Team & Program Director, MRCT Center
Rebecca Li, PhD,CEO Vivli
Alex Senra, Executive Assistant, Vivli
Olchey Tchavyntchak,Research Assistant, MRCT Center
Reproductive Health Considerations in Clinical Research
The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. The changing landscape of reproductive rights in the U.S. requires further consideration by clinical research stakeholders. Among other concerns, reproductive health intersects with clinical research with respect to the privacy of clinical trial participants.
The MRCT Center has started initial work to better understand whether and how reproductive privacy risks are addressed in study protocols, and particularly in informed consent documents. We are also exploring, through interviews with IRB chairs and research leaders across the country, existing approaches to reproductive health privacy protections and participant communication in single and multi-site trials.
Through this process, we are also working to identify recommendations for improved practices, which we plan to develop into a practical toolkit. The toolkit will include guidance documents on key privacy considerations, recommendations for notifying participants of privacy risks and communicating the importance of pregnancy reporting, best practices for addressing incidental pregnancies in research, and guidelines on medical record documentation. It will also explore the protections afforded by and the limits of Certificates of Confidentiality upon which the research community has relied.
OBJECTIVES
Evaluate current practices regarding reproductive privacy risks in clinical research informed consent forms and develop standardized guidance for addressing these concerns.
Develop resources to help research institutions mitigate participant privacy risks in the pregnancy testing and reporting processes, and to support research teams in communicating the risks to staff and participants.
Create standardized guidance for multi-site trial investigators to effectively manage the complexities of conducting research across jurisdictions.
KeY MILESTONES
January 2025: IRB protocol, “Pregnancy-Related Privacy Risks in Clinical Trials: Understanding Current Risks and Approaches,” approved
The MRCT Center works to improve the integrity, safety, and rigor of global clinical research by shaping policies that foster ethical, responsible, and accessible research practices. Contributing to policy engagement and public dissemination by submitting public commentary on regulatory proposals, draft guidance, and policies ensures that evolving frameworks, guidelines, and rules reflect the needs of research participants, sponsors, investigators, and the broader scientific community. Our ongoing engagement demonstrates our dedication to strengthening research integrity through thoughtful feedback on evolving regulations, promoting participant protection and ethical considerations, and encouraging innovation and practical implementation. Our submissions address a wide range of critical topics, shaping policies and practices that impact sponsors, researchers, and participants in the U.S. and worldwide. These contributions help ensure that research remains rigorous, responsible, and accessible.
OBJECTIVES
Enhance research integrity by providing thoughtful comments on evolving federal regulations to ensure clinical research remains ethical, transparent, and responsible.
Promote participant protection by advocating for global policies and practices that prioritize the rights, safety, and inclusion of research participants.
Encourage ethical innovation by supporting regulatory frameworks that foster advancement while maintaining rigorous ethical and practical standards.
Foster stakeholder engagement by bridging the needs of sponsors, researchers, and participants, contributing to policy writing and regulatory discussions that shape effective, transparent, and patient-centered research.
KeY MILESTONES
Public comments submitted to federal and international agencies
project Leadership & sTAFF
Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
Julia S. Etkin, MBE Candidate, Research Assistant II, MRCT Center
Research Ethics Committee & Regulatory Systems Optimization
TRACE (Trial Regulatory and Clinical Ethics Optimization) is a dynamic initiative to strengthen and streamline clinical trial regulatory and ethics systems across Africa. Its mission is to remove barriers to clinical research by streamlining review processes, reducing duplication, and establishing clear, efficient timelines.
Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.
The MRCT Center, as a member of TRACE’s Core Project Team and lead of the Capacity Building & Accreditation and Funding Models sub-teams, is working alongside the African Vaccine Regulatory Forum (AVAREF) and Garnet Partners, with funding support from the Gates Foundation, to design and implement sustainable regulatory and ethics solutions.
In close collaboration with local stakeholders, TRACE co-develops tools, templates, and resources tailored to the needs of African ethics committees. It promotes inter-institutional coordination and cooperation.
By bringing together national ethics committees (NECs), institutional review boards (IRBs), regulatory agencies, and sponsors, TRACE fosters a transparent, efficient, and sustainable environment for clinical research oversight. The initiative’s goal is to position Africa as a leading hub for clinical research, with pilot efforts currently underway in Rwanda, Tanzania, Zimbabwe, Nigeria, and, more recently, Kenya.
As part of its role, the MRCT Center leads national system assessments using the WHO Global Benchmarking Tool for Ethics Committees, provides targeted training and capacity-building programs for NECs, and supports the implementation of IRB reliance strategies. It is also collaborating with stakeholders to design a model fee structure and contributing to long-term financial sustainability and regulatory alignment.
To further support training, the MRCT Center offers an online, on-demand training course on Ethics and Review of Interventional Clinical Research available free on the WHO Academy platform. A follow-up course, Ethics and Review of Interventional Clinical Research II, is currently in development and expected in fall 2025.
Ultimately, TRACE is committed to establishing a sustainable, efficient, and globally dependable landscape for clinical research across Africa by tackling persistent challenges such as manual workflows, redundant reviews, and inconsistent timelines.
OBJECTIVES
Ethics Systems Strengthening: Enhancing NEC and IRB capabilities, developing accreditation frameworks, and operationalizing a national accreditation program.
Capacity Building: Providing comprehensive training, curriculum development, and resource support to empower ethics committees and regulatory authorities.
Financial Sustainability: Creating equitable fee structures, implementing differentiated charging models, and constructing robust financial sustainability strategies for NECs.
Integration with National Authorities: Facilitating the alignment of ethics systems with national regulatory infrastructures.
Regulatory Optimization: Simplifying submission pathways and review procedures to reduce ambiguity and inefficiency.
KeY MILESTONES
December 2025: Visit to Kenya to convene key stakeholders, including NACOSTI, PPB, and ISERCs from Moi Hospital and KEMRI, to support their participation in TRACE
August 2025: Financial Sustainability sub-team kickoff meeting
July–August 2025: Core team face-to-face meeting in Kigali to discuss project direction with participating countries
July 2025: Capacity Building sub-team kick-off meeting
June 2025: Visit Zimbabwe and Tanzania for gap and opportunity assessment
April–May 2025: Visit Nigeria and Rwanda to consult with NECs and regulatory bodies on gaps and opportunities
February 2025: Kick-off meeting with core team for the Africa Clinical Trial Regulatory and Ethics System Optimization project
October 2024: Released online course “Ethics and Review of Interventional Clinical Research”
February 2024: Meetings in Rwanda and Zimbabwe to strengthen and sustain the clinical trial ecosystem in Africa
January 2024: Meetings in Ethiopia for assessment of clinical trial system
May 2023: Presented MRCT Center’s capacity building effort at AVAREF meeting in Cameroon
December 2022: Clinical Trial Optimization visit in Kenya and Nigeria
March/April 2022:Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa- Part 2
September 2021: Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa – Part 1
project Leadership & sTAFF
Barbara E. Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center
Willyanne DeCormier Plosky, DrPH, Program Director, MRCT Center
Hayat Ahmed, MSc, Program Manager, MRCT Center
Lauren Otterman, MBHL, Project Manager, MRCT Center
While clinical trials contribute only a small percentage of greenhouse gas (GHG) emissions within the healthcare sector (estimated to contribute 8-12% of overall healthcare related GHG emissions), each stakeholder is responsible for understanding one’s contributions, and all must play their part in mitigation efforts.
The MRCT Center continues to explore the complex set of issues related to environmental sustainability in clinical trials. In Europe and many other parts of the world, the focus on environmental sustainability is prominent with well-established efforts to study and reduce GHG. The U.S. interest and investment, strong in many individual states and companies, is variable.
A series of in-depth discussions with multiple parties identified critical areas and potential approaches, such as the development of standardized carbon footprint analyses for clinical trials and the assessment of current emission reporting standards.
Building on these insights, we advocated for multi-stakeholder investment in environmentally sustainable practices across the clinical trial lifecycle, including practical and actionable steps each stakeholder in the clinical trial enterprise can take and makes the case for stakeholder consideration of action in the collective effort to achieve net zero emissions while maintaining the value and integrity of clinical trials. A key priority is ensuring that only informative and necessary trials that generate meaningful and actionable data are conducted. Additionally, we recognize that opportunities for improvement exist at every stage of the clinical research lifecycle.
Increase awareness of environmental sustainability in clinical trials through engagement with stakeholders, supporting existing initiatives, and positioning the MRCT Center as a collaborator and possible convener.
Amplify existing efforts to garner buy-in from all involved stakeholders.
Elucidate mitigation opportunities while addressing the complexities and trade-offs accompanying decision-making for clinical trials.
KeY MILESTONES
July 22, 2024: Lisa Koppelman (virtually) presented MRCT Center findings to date at a meeting of The Greener Trials Consortium (UK)
March 2024: Completed a thematic analysis of scoping calls
February 2024: Completed a series of 6 group scoping calls with 4-6 participants each and several additional individual scoping calls, representing the UK, Europe, the US, and South Africa; Stakeholders included academic researchers; clinical trialists; industry
project Leadership & sTAFF
Lisa Koppelman, MSW, LICSW, MPH, Program Director, MRCT Center
Trevor Baker, MS, Program Manager, MRCT Center
Barbara Bierer, MD, Faculty Director, MRCT Center
Project Resources
Artificial Intelligence (AI) and Clinical Research
Artificial intelligence (AI) in clinical research is being deployed across all aspects of research, both as an experimental intervention, and as an ancillary tool to support the administration of research and optimize trial design, planning, recruitment, and analysis. The MRCT Center established this project to explore the actionable, practical, and ethical considerations when using artificial intelligence (AI) in clinical research. As with all research involving human participants, effective and efficient use of AI in clinical research should be grounded in existing ethical principles and governing regulations to protect participants.
In 2024, the MRCT Center, in collaboration with WCG Clinical, convened a multidisciplinary task force to develop resources to address ethical and regulatory challenges during the IRB review of clinical research involving AI as the experimental intervention. In 2025, the task force publicly launched the Framework for Review of Clinical Research Involving Artificial Intelligence.
In 2026, the MRCT Center and WCG Clinical task force expanded its membership and focus to developing actionable, practical deliverables for the use of AI in the administration of clinical research.
This new project direction examines the use of AI in areas such as protocol development, trial modeling, site selection, participant recruitment and outreach, data collection and management, statistical analysis, and post-marketing requirements and aims to develop stakeholder responsibilities and guidance on responsible oversight, institutional responsibilities, and best practices for monitoring of AI systems.
In 2025, the MRCT Center also launched a webinar series on the use of digital twins and synthetic data to create virtual simulations of patient outcomes and how these approaches aim to improve the efficiency of clinical trials. The MRCT Center continues to work to evaluate the technical, ethical, and practical considerations involved with the use of digital twins and synthetic data.
OBJECTIVES
Define and analyze the current critical ethical and regulatory challenges of deploying AI across the clinical research lifecycle.
Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, sponsors, and investigators to protect participants in research as AI’s role continues to grow.
Identify new resources and tools needed by stakeholders in the clinical research ecosystem.
KeY MILESTONES
February 2026: Convened the first meeting of the MRCT Center and WCG Clinical task force on the use of AI in the Administration of Research.
November 2025: Held a webinar in the AI Digital Twins and Synthetic Data series on Practical Use Cases in Clinical Research.
October 2025: Organized a panel during the MRCT Center’s Annual Symposium on the opportunities and challenges posed by the integration of AI in the informed consent process.
September 2025: Launched the first webinar in a series on AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
June 2025: Held a webinar to launch the Framework for Review of Clinical Research Involving Artificial Intelligence
November 2024: Organized a panel session during the MRCT Center’s Annual Symposium on Expanding the Uses of Data and AI in Support of Clinical Trials, beginning the Digital Twins and Synthetic Data workstream.
March 2024: Convened the first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.
project Leadership & sTAFF
Barbara Bierer, MD, Faculty Director, MRCT Center
Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
Trevor Baker, MS, Program Manager, MRCT Center
Olchey Tchavyntchak, Research Assistant, MRCT Center
There is justified excitement about the emergence and potential of cell and gene therapies (CGT): a number of CGTs have recently received market approval and hundreds more are in preclinical and/or clinical development. As a new therapeutic class, there is still much to learn about the benefits and risks of CGT, necessitating complex decision-making and long-term follow-up in many trials. Many CGTs also have complex manufacturing and/or supply chain challenges. For these reasons and because of the need for specialized clinical expertise, trial sites are often geographically limited. The CGT project aims first to ascertain and characterize the ethical, regulatory, and logistical issues that are arising in the specific context of CGT research and development. We will then work to address and mitigate these challenges through a collaborative, multi-stakeholder approach.
OBJECTIVES
Identify and characterize ethical, regulatory, and logistical challenges arising in the context of global research and development of cell and gene therapies.
Employ a multi-stakeholder approach to co-develop actionable and practical mechanisms for addressing these challenges to support efficient, safe, and respectful clinical development of CGT products.
KeY MILESTONES
January 2026: Released Podcast “Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies” on YouTube and Spotify
November 2025: Carolyn Chapman presented an overview of the LTFU Toolkit as a panelist in WCG’s webinar, “Ethical Oversight in Gene Therapy Long-Term Follow-Up”
November 2025: Held Webinar, Long-Term Follow-Up for Gene Therapies: Toolkit Release
November 2025: Released “Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies, v.1 [For Public Comment]”
October 2025: Held panel at the MRCT Center’s Annual Symposium: “Long-Term Follow-Up (LTFU): Key Deliverables and the Path Forward” (recording available)
June 2025: Held webinar: “Patient-Centered Long-Term Follow-Up for Gene Therapies”
June 2025: Carolyn Chapman spoke at the June 2025 Bridging the Gap webinar, “Ethical Issues in CGT Trials: Benefits, Risks, Long Term Follow-Up and Beyond,” sponsored by Azenta Life Sciences and the Emily Whitehead Foundation
May 2025: Two poster presentations at ASGCT meeting in New Orleans, Louisiana
May 2025: Held webinar: “Innovative Approaches for Gene Therapy Long-Term Follow-Up”
December 2024: Carolyn Chapman spoke at the Institute for Advanced Clinical Trials for Children (I-ACT)’s webinar, “Science Applications and Ethics of Cell and Gene Therapy”
December 2024: “What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges” webinar, co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group
September 2024: Launch of the Long-Term Follow-Up Working Group and of the Strategic Advisory Committee
May 2024: Poster presentation at ASGCT meeting in Baltimore, Maryland
December 2023: MRCT Center Bioethics Collaborative, “Gene Therapies: Probing the Ethics”
project Leadership & sTAFF
Carolyn Riley Chapman, PhD MS, MRCT Center. Lead Investigator, Brigham and Women’s Hospital and Member of the Faculty, Harvard Medical School.
Barbara E. Bierer, MD, Faculty Director, MRCT Center.
Emina Berbic, Program Manager, MRCT Center.
Mena Shaikh, Student Researcher, MRCT Center.
Olchey Tchavyntchak, Research Assistant, MRCT Center.
Lindsey Henriques, Graphics and Information Design Specialist, MRCT Center.
Oversight and Implementation of Decentralized Elements in Clinical Trials
The MRCT Center is collaborating with Medable and other organizations to address the oversight and conduct of decentralized and hybrid clinical trials (collectively, DCTs), with a focus on planning and monitoring the trial appropriately.
While almost every trial utilizes some elements of technology, DCTs are highly variable in terms of the elements of ‘decentralization’ deployed throughout the trial, from remote recruitment utilizing social media, electronic consent, remote visits through either virtual visits or local providers, and use of devices and software for data collection, among others. There is also significant variability in IRB understanding of DCTs and, therefore, often prolonged delay in approval.
Working with a multi-stakeholder task force, the first initiative of this project addresses the ethical review of DCTs, focusing on how DCTs differ from traditional clinical trials. Next, specific recommendations for the roles and responsibilities of PIs (including PI oversight) and sponsors will be addressed.
OBJECTIVES
Provide guidance and tools for IRBs, sponsors, investigators and their study teams regarding ethical review and approval of DCTs
Consider the specific responsibilities of principal investigators, sub-investigators, study staff, sponsors, and vendors in DCTs
Develop resources for use by stakeholders involved in DCTs
KeY MILESTONES
February 2024: Launch of “PI Oversight in DCTs” taskforce
March 2023: A multi-stakeholder workgroup of ~30 people has completed a series of meetings, and the core team developed deliverables for ethical review of DCT trials
June 2022: Conclusion of task force meetings; key deliverable development begins
October 2021: Launch of DCT taskforce
project Leadership & sTAFF
Barbara Bierer, MD., Faculty Director, MRCT Center
Emina Berbic, MPH, Program Manager, MRCT Center
Pam Tenaerts, MD., Chief Scientific Officer, Medable, Inc.
Andre Chiriac, MD., Vice President of Medical, Medable, Inc.
The MRCT Center is guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote audience understanding and empowerment. Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.
As such, the MRCT Center launched an effort in 2018 to develop clinical research-focused health literacy resources with a workgroup of diverse representatives from across the research ecosystem that would support the integration of health literacy strategies across the clinical development life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.
All of us here at the MRCT Center strive to develop tools and resources that promote understanding, especially when the audience includes patients, participants, and caregivers. Our plain language, patient-centric Clinical Research Glossary, which was piloted in 2020, continues to grow via a collaborative consensus-building workgroup process, and was adopted as a CDISC global standard in April 2023.
The most recent version of the Clinical Research Glossary includes 216 words and definitions, customized images, and additional details and resources that provide users with valuable background information. New terms and definitions are released every September. If you’d like to be notified when new terms are available, please fill out this form.
Other Health Literacy in Clinical Research efforts include the 2025 release of a suite of Data Literacy Infographics, an ongoing virtual Health Literacy Training and Checklist for IRBs, and a newly initiated project to update the Health Literacy in Clinical Research website content.
Objectives
Establish and support initiatives that increase the use of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
Develop and share resources with sponsors and funders, investigators and their study teams, and institutional review boards that maximize their efforts to integrate health literacy principles throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
Promote the use of plain language in clinical research via a harmonized, patient co-developed Clinical Research Glossary that can be used across the research industry, and used by research professionals and potential participants to foster clear, bi-directional information exchange.
