ABOUT TRACE

The TRACE Project (Trial Regulation and Clinical Ethics Optimization) is a multi- country initiative launched in 2025 to strengthen and harmonize clinical trial ethics and regulatory oversight across selected African countries. The project aims to build a coordinated, transparent, predictable and efficient environment for ethics and regulatory review, strengthening national systems and supporting alignment with regional frameworks such as AVAREF and the African Medicines Agency (AMA).

TRACE’s optimization efforts are implemented through five workstreams: Capacity Building & Accreditation, Harmonization of policies and SOPs, Digitalization, Financial Sustainability, and Communications. These workstreams enhance the performance and professionalism of ethics committees, strengthen governance, and advance digital transformation to improve workflow transparency, efficiency and data-driven decision-making.

Through these coordinated efforts, the TRACE project addresses systemic bottlenecks and improves the predictability and quality of ethics and regulatory review processes. The project supports capacity building of Ethics Committee members, IRB accreditation systems, harmonized SOPs and governance documents, quality assurance mechanisms, reliance pathways, and alignment with AVAREF recommended clinical trial review timelines.

MISSION

To harmonize, strengthen, and digitalize the clinical trial ethics oversight ecosystem in participating African countries, while supporting improved coordination with regulatory authorities. TRACE project aims to enhance transparency, predictability, and efficiency in review processes and to enable safe, ethical, high-quality research.

VISION

An Africa-led clinical research ethics oversight environment that is transparent, efficient, predictable and trusted; one that protects research participants, supports innovation, and is better prepared to respond to public health priorities and emergencies.

KEY OBJECTIVES

To streamline and harmonize clinical trial ethics review processes in participating countries.
Build capacity for National Ethics Committees (NECs) and Institutional Review Boards (IRBs), in collaboration with National Regulatory Authorities (NRAs).
Strengthen and optimize digital systems for ethics and clinical trial oversight to improve efficiency, transparency and coordination within each TRACE country.
Engage policymakers, regulators and institutional stakeholders to strengthen ethics governance and coordination.
Ensure all NECs implement a financial sustainability plan to support long- term operational effectiveness.

EXPECTED OUTCOMES

Efficiency & Quality of Clinical Trial Application (CTA) review processes: Countries deliver CTA decisions in line with AVAREF recommended timelines.
Quality assurance & Peer review: Countries introduce quality-assurance mechanisms, including peer-learning approaches and agreed-upon quality benchmarks for ethics review.
Digital CTA review systems: Countries strengthen or adopt an efficient digital CTA platform for ethics oversight to improve transparency and reduce delays.
Accreditation: Countries advance NEC and IRB systems and work toward implementing context-appropriate accreditation and certification models.
Regulatory reliance: Countries implement Institution Review Board (IRB) reliance models for multi-site clinical trials.
Financial sustainability: Countries develop sustainability plans for NEC operations, including analysis of fee structures, cost elements, and long- term financing options with the aim to achieve 100% self-funding within five years.

WHAT WE DO

Strengthening national ethics systems for clinical research.

TRACE project’s primary focus is on strengthening national ethics systems for clinical research, while supporting closer coordination with regulatory authorities to ensure transparent, predictable, and efficient oversight. We support countries to harmonize ethics review processes, build institutional capacity, adopt digital
oversight tools and establish sustainable governance and financing models.