Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State University
Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
Results from a Delphi study on data management competencies
Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
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Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.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, and Nigeria.
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
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
The Convergence Project is pleased to invite you to an upcoming virtual event hosted by the MRCT Center, focused on workforce development strategies to support a more dynamic and competitive clinical research workforce.
This meeting will bring together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics will include workforce development, targeted recruitment, and actionable steps to drive systemic improvements. You’ll have the opportunity to engage with panelists leading programs in Georgia, North Carolina, West Virginia, and other states across the country.
We hope you can join us for this important conversation. We look forward to your participation!
Developed by: MRCT Center, in collaboration with ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design.
The MRCT Center is currently developing a series of in-depth training modules to complement the video.
Developed by: MRCT Center, in collaboration with the World Health Organization
Description: This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide.
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Roche Portugal, and Agency for Clinical Research and Biomedical Innovation (AICIB).
