Resource Type: Tools

Proportionate Oversight in Decentralized Clinical Trials (DCTs)

Decentralized clinical trials (DCTs) can reduce participant burden and broaden access, but they also raise critical questions about oversight, roles, and responsibilities. Developed by the MRCT Center and Medable, with input from the Investigator Oversight in DCT Task Force, these practical tools help sponsors, investigators, and local healthcare providers (HCPs) apply a risk-proportionate approach to trial oversight. The resources and tools support oversight across decentralized clinical trial activities, from protocol design and site-level oversight to the participant visit itself.

Project background

In May 2023, the U.S. Food and Drug Administration (FDA) released its guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, providing recommendations for the conduct of clinical trials that include decentralized elements.

Shortly after, the MRCT Center and Medable convened a multi-stakeholder discussion to explore the implications of the guidance, with particular focus on investigator responsibilities and oversight in decentralized clinical trials (DCTs). Participants included representatives from the FDA, the Office for Human Research Protections (OHRP), academic institutions, sponsors, and contract research organizations (CROs).

The challenge

As clinical trial activities and data collection increasingly occur outside of traditional research sites, questions emerged regarding the scope and implementation of investigator oversight. Key challenges included:

  • Clarifying investigator responsibilities and oversight expectations in decentralized clinical trials.
  • Defining how oversight should be implemented when investigators do not have direct supervisory or contractual relationships with individuals conducting trial activities or collecting study data.
  • Distinguishing the respective roles and responsibilities of investigators, sub-investigators, delegated study team members, and local healthcare providers involved in trial conduct.

Why This Work Matters

The rapid adoption of decentralized trial approaches has created new opportunities to improve trial accessibility and participant engagement. At the same time, it has introduced uncertainty regarding oversight, accountability, and role delineation. To address these challenges, the MRCT Center and Medable launched a collaborative initiative to develop practical tools and resources that support appropriate investigator oversight in trials with decentralized elements. Together, these tools and resources represent a coherent, integrated system for decentralized trial conduct—sponsor-driven design, investigator-calibrated oversight, HCP-executed delivery, and a clear escalation structure when reality diverges from plan.

Project Tools:

PRACTICAL GUIDE

How These Four Documents Work Together: A Practical Guide for Sponsors, Investigators, and HCPs

We recommend first reviewing our How These 4 Tools Work Together document before accessing the Oversight in DCTs Framework and Tools.

TOOL

Optimizing Decentralized Elements in Clinical Trials (DCTs)

A practical guide to help investigators understand sponsors’ responsibilities when designing and implementing trials with decentralized elements.

TOOL

Proportional Oversight Framework for Clinical Trials with Decentralized Elements

A decision-support framework that helps investigators, sponsors, and other trial stakeholders align investigator oversight with critical-to-quality factors and identified risks in trials with decentralized elements.

TOOL

Clinical Trial Instruction Sheet for Local Healthcare Providers (HCPs)

This model HCP Instruction Sheet is meant to be pre-filled by the sponsor and the site, so the local health provider knows what is being asked of them.

TOOL

HCP Check-In Questions for Participants

A consistent way to ask how a participant is doing between visits, with worked responses to nine situations, ranging from a withdrawal request to adverse events.

Related Events & Resources

Tool Release Webinar for Proportionate Oversight in Decentralized Clinical Trials (DCTs): New Resources and Practical Tools
Oversight and Implementation of Decentralized Elements in Clinical Trials
IRB/EC Considerations for DCT Review
Ethical Considerations for Decentralized Clinical Trials: Tools, Resources and Best Practices
Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline

Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Tools

Released on: September 22, 2026

Explore the C3PT Blueprint comprising a multi-stakeholder Position Narrative, and practical implementation tools designed to strengthen academic-industry collaboration in pediatric oncology platform trials. Together, these resources provide a roadmap for overcoming barriers, streamlining partnerships, and accelerating the development of innovative therapies for children and young people with cancer.

The C3PT Blueprint

You can click on the labels below to open each tool in a new tab

Check out the C3PT project page to learn more:

Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT)

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.

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

Toolkit

Released on: January 23, 2026

Long-term follow-up (LTFU) studies of gene therapy (GT) recipients are crucial for understanding the overall benefit-risk profile of these innovative products. However, LTFU studies are challenging to design, conduct, and execute, and pose significant burdens on both patients and sponsors.

On January 23, 2026, the MRCT Center released version 2.0 of the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies (CGT), revised and improved based on feedback of a draft that had released for public comment.  

The MRCT Center CGT Toolkit is comprehensive and provides background information, practical resources, and recommendations to support best practices for LTFU studies for both investigational and approved gene therapies—balancing the generation of critical long-term safety and efficacy data with the need to reduce burdens placed on participants, caregivers, sponsors, and investigators. 

Compared to the draft version, the updated Toolkit v2.0 includes two new resources, an Executive Summary and a Patient Resource, which have also been released as standalone versions. Additions included new and/or revised charts, tables, and resources. The Toolkit explores ideas for how LTFU studies could be improved in the future, raising questions that the field should discuss and address.

The Toolkit enables easy navigation to various sections and subsections via multiple clickable, interactive toolbars. The sections are as follows, with the core elements in bold font:

  • Executive Summary (new in v2.0)
  • Introduction and Background
  • Types of LTFU studies for GTs
  • Flowcharts
  • Guiding Principles
  • Considerations and Recommendations for the Design, Conduct, and Reporting of LTFU Studies for GTs
  • Looking Forward
  • Key Design Elements of LTFU Studies for FDA-approved GTs
  • Regulatory Guidance Relating to LTFU of GTs
  • Patient Resource: Long-Term Follow-Up Studies After Gene Therapy (new in v2.0)
  • Compiled Glossary of Scientific LTFU-Related Terminology
  • Easy-to-Understand (Accessible) LTFU-Related Definitions from the MRCT Center’s Clinical Research Glossary
  • Appendices
  • List of Acronyms and Abbreviations Used
  • References Cited

Please email us at mrct@bwh.harvard.edu with any questions or suggestions regarding the Toolkit.

2026_LTFU-Toolkit-Version02_01-23-2026Download

Navigation Highlights

The Toolkit incorporates several interactive features designed to support intuitive navigation and ease of use:

  • Clickable Table of Contents for rapid access to major sections and subsections.
  • Right-hand vertical navigation bar on every page, enabling quick movement between tools within the document.
  • Interactive table of LTFU study types, mirrored by color-coded tabs that remain clickable throughout the associated pages.
  • Secondary navigation bar at the top of each page within the Considerations & Recommendations section. This feature highlights your location within the nine subsections, allows you to jump directly between subsections by clicking the dots, and includes a grey diamond icon that returns you to the full list of subsections.
Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies
Long-Term Follow-Up for Gene Therapies: Toolkit Release
MRCT Center Annual Symposium: Panel 3 – Cell and Gene Therapies Long-Term Follow-Up (LTFU).
Panelists:
Pamela Tenaerts, MD, MBA, Chief Medical Officer, Medable
Daniel Kavanagh, PhD, RAC – Senior Scientific Advisor, Gene Therapy, Vaccines, & Biologics, WCG
Lara Gehl, Executive Director, Global Trial Management – Bristol Myers Squibb
𝗠𝗼𝗱𝗲𝗿𝗮𝘁𝗼𝗿:
Carolyn Riley Chapman, PhD, MS – Lead Investigator, Brigham and Women’s Hospital; Member of the Faculty, Harvard Medical School
Patient-Centered Long-Term Follow-Up for Gene Therapies
Innovative Approaches for Gene Therapy Long-Term Follow-Up
Cell and Gene Therapies

Research Ethics Review: Guidance for Clinical Trials

Tool

Published: July 16, 2025

This guidance document is intended to be used as a tool to supplement the review, discussion, and deliberation of Research Ethics Committees reviewing clinical trial protocols.

This tool was developed by Barbara E. Bierer, MD (The MRCT Center of Brigham & Women’s Hospital and Harvard), Jeffrey D’Souza, PhD (University of Toronto), Caroline M. Kithinji, PhD (Kenya Medical Research Institute), and Winfred B. Nazziwa, MS (Uganda National Council for Science & Technology), in collaboration with the African Vaccines Regulatory Forum (AVAREF).

With Fillable Comment Boxes
For Print – without fillable comment boxes
2025_MRCT_AVAREF_Ethics-Review-Tool_07-10-2025_Comment-boxes_FillableDownload
Research Ethics Committee Systems Optimization


LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

Toolkit

Published on: November 18, 2024 and updated on May 30, 2025

Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the clinical research guiding principles in the Belmont Report of respect for persons, beneficence, and justice, we have developed a toolkit to support equitable participation of people who are LGBTQIA+. The toolkit contains seven tools. Any audience can use the full toolkit, although it should be noted that first four tools are directed more toward sponsors and research teams, and the latter three are directed more toward participants. The first four tools were publicly released individually in the spring of 2024, and the latter were released in November 2024. We invite you to explore the full toolkit or to focus on the specific tools that you find most important to your individual or organizational journey in clinical research.

Download the LGBTQIA+ Toolkit
LGBTQIA+ Resources and Webpage
2025-05-30 LGBTQIA Toolkit_with Appendix_finalDownload

LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective

Exit Survey Inclusive of the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024 and updated on May 30, 2025

The “Exit Survey Inclusive of the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit and the third of three tools in the section of the Toolkit directed more toward participants. It is important for participants in clinical research activities to give feedback about their experiences. This feedback helps research teams and organizations better understand the participant’s experience of the research activity and learn where they can improve on efforts to empower research participants and the participants’ supporting families, friends, and communities. One way to gather feedback is through a survey, which may be given to participants periodically (e.g., once a month), and/or (as an exit survey) at the end of research activities. In this tool, we aim to show examples of the topics that participants may be asked about in a survey or interview or, if not asked, that the participant may wish to share with the research team in a patient portal, email, or other format.

Please note that the Exit Survey Inclusive of the LGBTQIA+ Participant Perspective has been comprehensively updated in the 2.0 version, particularly in questions 21c-f and in the footnotes for those questions and response options. We have also included a new appendix to this tool, which provides a summary of Key Resources and Recommendations for SOGI Data Collection. These resources and recommendations are drawn from documented best practice and are meant to support researchers designing surveys and research participants that are considering how they might give feedback on their participation experience.

LGBTQIA+ Toolkit
LGBTQIA+ Resources and Webpage
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool07Download

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective


Participant Questionnaire from the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024 and updated on May 30, 2025

 The “Participant Questionnaire from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the second of three tools in the section of the Toolkit directed more toward participants. There are numerous questions that participants may want to ask as they move from thinking about possible trials and sites to starting the process of enrolling and participating in a trial. Some of these questions may be covered by informational materials given to participants during the informed consent process and study visits, and some may not be. This list is to help participants prepare so that they can get the answers that they need and feel comfortable before continuing with the trial. The Participant Questionnaire tool is divided into sections that include questions to ask the research team, questions you may want to ask family, friends, and others you trust, and questions to ask yourself. It includes questions that anyone might want to ask and adds questions that LGBTQIA+ people (and/or their accompanying friends and family) might also want to ask.

LGBTQIA+ Toolkit
LGBTQIA+ Resources and Webpage
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool06Download

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective


Site Feasibility Decision Tree from the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024 and updated on May 30, 2025

The “Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the first of three tools in the section of the Toolkit directed more toward participants. This tool is meant to empower potential LGBTQIA+ participants to assess whether a site may be trustworthy and welcoming. This tool is structured in tiers, with checkpoints in between. The first tier is potential capacity, where we provide prompts, or “determination factors” based on what IS happening at a site (or in the area nearby) that LGBTQIA+ people can use in considering whether the site is potentially a good place to participate in a study. In the second tier we focus on “historical capacity,” or the things that the site HAS/HAD done to support the well-being of LGBTQIA+ people that may inspire confidence that the site is trustworthy.

LGBTQIA+ Toolkit
LGBTQIA+ Resources and Webpage
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool05Download

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective

Model Diversity Action Plan (DAP)

Tool

Published: September 4, 2024

The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.

Download the Model DAP
View the Global Representation Roadmap
08-27-2024_DAPDownload