Resources

• Podcast

Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies

• Meeting Summary
• Video

2025 Annual Symposium

• Annual Report

2025 MRCT Center Year in Review

• Training

Ethics and Review of Interventional Clinical Research: Part 2

• Tools

Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies

• Training

Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Urdu)

• Meeting Summary

Therapeutic Misconception Revisited

• Presentation
• Proceedings
• Video

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency: December 2025

• Webinar

Mitigating Financial Toxicity for Participants in Clinical Trials: Best Practice Considerations & Recommendations for Sponsors

• Public Comments

Public Comments submitted to TEHDAS2 on targeted issues related to the European Health Data Space

• Webinar

AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

• Publication

Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review

• Guidance

EC/IRB Guide to Understanding Post-Trial Continued Access

• Webinar

Long-Term Follow-Up for Gene Therapies: Toolkit Release

• Webinar

Applied Health Literacy: Using Teach-Back in Conversations about Clinical Research

• Publication

Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov

• Video

Long-Term Follow-Up for Gene Therapies: Key Deliverables and the Path Forward 

• Publication

A Scoping Review of Challenges in Pediatric Health Technology Assessments with a Focus on Pharmaceutical Interventions

• Webinar

AI Digital Twins and Synthetic Data: Application to Clinical Trials

• Public Comments

E21 Inclusion of Pregnant and Lactating Women in Clinical Trials

• Webinar

Continued Access to Investigational Products: Guiding Equitable and Fair Decisions

• Meeting Summary

Medical Need or Market Opportunity: Setting Research Priorities

• Publication

Disparate data retention standards in biomedical research

• Tools

Research Ethics Review: Guidance for Clinical Trials

• Webinar

Patient-Centered Long-Term Follow-Up for Gene Therapies

• Webinar

Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process

• Webinar

A Framework for AI Adoption and Oversight in Clinical Research

• Framework

Framework for Review of Clinical Research Involving AI

• Other

Implementing the Clinical Research Glossary: Case Use Collection

• Meeting Summary

Is it Time to Retire the Concept of Deidentification?

• Video

How to Submit Comments on Glossary Definitions via JIRA

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency, June 2025

• Tools

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

• Tools

Site Feasibility Decision Tree from the LGBTQIA+ Perspective

• Video

“What’s Your Why?”: Amplifying Participant Voices in Clinical Trials Week 

• Tools

Exit Survey Inclusive of the LGBTQIA+ Perspective

• Podcast

Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist

• Case Study
• Tools

LGBTQIA+ Inclusion – Inclusive Imagery

• Tools

LGBTQIA+ Inclusion – Inclusive Language Checklist

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist

• Publication

Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment

• Publication

Patient-centered long-term follow-up for gene therapies aligns with ethics and science

• Podcast

Podcast Episode 4: Clinical Trials in Latin America

• Publication

Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions

• Publication

An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity

• Publication

Benefits that Offset Research Risks and Burdens are Qualitatively Different

• Webinar

A Shared Language for Clinical Research: How Technical Organizations are Implementing the Clinical Research Glossary

• Webinar

Innovative Approaches for Gene Therapy Long-Term Follow-Up

• Publication

Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct

• Podcast

Advancing Pediatric Platform Trials: A Conversation with Dr. Danny Benjamin

• Publication

Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America

• Framework

Framework: Post-trial, Continued Access Responsibilities to Investigational Significant-Risk Devices – Scenarios that require further consideration

• Meeting Summary

Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact

• Publication

Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions

• Webinar

Data Literacy in Clinical Research: Enhancing Trust and Transparency

• Webinar

Global Development of Clinical Research Workforce: Tools and Resources

• Flyer
• Video

Data Literacy: MRCT Center and PHUSE Resources

• Publication

Comment: A global call to action for disability inclusion in health research

• Guidance

Working with Partner Countries to Strengthen Research Capacity Relating to Global Representation

• Guidance

Embedding Ethical Considerations Relating to Global Representation

• Publication

Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research

• Public Comments

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry

• Meeting Summary

Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research

• Webinar

Workforce Development: Opportunities to Engage and Retain Talent in Clinical Research

• Public Comments

Draft Guidance: Considerations for Including Biopsies in Clinical Trials

• Publication

The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative

• Public Comments

Comments Submitted: Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

• Publication

New Developments in Right to Try Legislation

• Publication

Analysis of the Choice of Control in Acupuncture Clinical Trials Involving Patients with Breast Cancer

• Publication

Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov

• Public Comments

Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

• Publication

Toward Justice and Community Empowerment in Genomics Studies on Sensitive Traits

• Public Comments

Public Comments submitted: “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice”

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency, December 2024

• Webinar

What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges

• Public Comments

Public Comments submitted: “Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons”

• Podcast

Podcast Episode 2: Trials Beyond Borders

• Tools

Participant Questionnaire from the LGBTQIA+ Perspective

• Principles

Principles of Post-Trial Responsibility: Continued Access to an Investigational Product

• Framework

Framework: Post-trial, Continued Access Responsibilities to Investigational Medicines

• Publication

Engaging children and adolescents in the design and conduct of paediatric research

• Publication

Towards A National Action Plan To Improve Representation In Clinical Trials

• Training

ICH E8(R1) Introductory Overview Video

• Webinar

Health Literacy Month Webinar Series

• Webinar

Designing PowerPoint Presentations to Support Health Literacy and Accessibility

• Training

Ethics and Review of Interventional Clinical Research: Part 1

• Training

Accessibility 101 Training Series

• Publication

Declaration of Helsinki – Revisions for the 21st century

• Webinar

Creating and Sharing Plain Language Summaries: One Team’s Experience

• Webinar

Designing Impactful Informed Consent Processes that Empower Participants

• Public Comments

Public Comments submitted: “Remarks for Rep. Robin Kelly’s Roundtable to Diversify Clinical Trials”

• Public Comments

Public Comments submitted: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies FDA-2021-D-0789”

• Tools

Model Diversity Action Plan (DAP)

• Tools

Global Representation Roadmap

• Publication

Creating educational materials about clinical research data for patients and the public

• Public Comments

Public Comments submitted: “Evolving the Network of the National Library of Medicine NOT-LM-24-001”

• Podcast

Podcast Episode 1: Trials Beyond Borders

• Public Comments

Public Comments submitted: “Request for Information on the National Institutes of Health Draft Public Access Policy”

• Publication

The PubPeer conundrum: Administrative challenges in research misconduct proceedings

• Public Comments

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

• Publication

E-Book: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

• Publication

Pediatric drug development issues during public health emergencies

• Publication

The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research

• Public Comments

Public Comments submitted: “NIH-OSP Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning”

• Publication

Editorial: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

• Public Comments

Public Comments submitted: “Federal Evidence Agenda on Disability Equity”

• Webinar

Accessibility 101: How to Write Alt-Text and Map Participant Journeys

• Public Comments

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status

• Publication

Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications”

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values”

• Public Comments

Public Comments submitted: “Declaration of Helsinki Public Comment Period Two”

• Publication

The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, by Carl Elliott. New York: W.W. Norton & Company, 2024

• Publication

Proposed Increases in Government Authority Over Research Misconduct Proceedings

• Public Comments

Public Comments submitted: “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products”

• Meeting Summary

Reciprocity in Research: Does the Principle of Justice Support Community Investment

• Public Comments

Public Comments submitted: “FDA-NIH Terminology for Clinical Research”

• Webinar

Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency June 2024

• Webinar

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

• Publication

A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19

• Publication

First, do no harm: a global perspective on diversity and inclusion in clinical trials

• Framework

Toward a National Action Plan for Achieving Diversity in Clinical Trials

• Public Comments

Comments Submitted: Draft Guidance, Key Information and Facilitating Understanding in Informed Consent; FDA-2022-D-2997

• Public Comments

Public Comments submitted: “Draft Guidance, Key Information and Facilitating Understanding in Informed Consent”

• Public Comments

Comments Submitted: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (FDA-2016-D-3561)

• Public Comments

Public Comments submitted: “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”

• Public Comments

Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Arabic)

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Portuguese)

• Webinar

The Clinical Research Glossary: New Words, New Opportunities

• Public Comments

Public Comments submitted: VolREthics initiative – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials

• Public Comments

Master Protocols for Drug and Biological Product Development

• Meeting Summary

Advancing Inclusion: Integrating Pregnant and Lactating People in Research

• Meeting Summary

Advancing Inclusion: Integrating Pregnant and Lactating People in Research

• Webinar

REACH: Advancing DEI in Human Participant Research

• Other

Essential Elements of Ethics – Statistics 2023

• Publication

Ethical Considerations in Decentralized Clinical Trials

• Meeting Summary

2023 Annual Meeting Proceedings

• Public Comments

Comment on the NPRM regarding regulations to title II of the Americans with Disabilities Act: Accessibility of Medical Diagnostic Equipment of State and Local Government Entities

• Meeting Summary

Gene Therapies: Probing the Ethics

• Public Comments

Public Comments on Declaration of Helsinki: Phase 1

• Project-Specific Website

Promoting Global Clinical Research in Children: An Overview

• Publication

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency 

• Public Comments

Comments on the Public Health Service Policies on Research Misconduct Notice of Proposed Rulemaking

• Publication

Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency November 2023

• Public Comments

Comment on the NPRM Request of the Office for Civil Rights (OCR) re: Discrimination on the Basis of Disability in Health and Human Services Programs or Activities