WHAT WE DO
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.
Through collaboration with ethics committees, regulators, and regional partners, TRACE advances high-quality, ethical and efficient clinical trial oversight that protects participants and strengthens trust in research.
PROJECT WORKSTREAMS
HARMONIZATION
Helps countries review and enhance their ethics governance frameworks in line with AVAREF, WHO and international good practices, while ensuring that improvements remain country-driven and context-appropriate.
Focus areas: Supporting countries in reviewing and updating laws, policies and governance documents related to ethical review. Harmonizing and strengthening SOPs and governance documents within NECs and across IRBs in each country. Supporting optimization of ethics review workflows and approval pathways, including in-country reliance mechanisms. Development of standardized tools, templates, and operational guidelines.
CAPACITY BUILDING & ACCREDITATION
Builds competencies and strengthens oversight systems across NECs and IRBs, while supporting better coordination with regulatory authorities.
Focus areas: Designing and delivering training programs (in collaboration with the MRCT center, AVAREF, WHO academy). Supporting registration and certification/accreditation processes for IRBs . Introducing ethics maturity concepts and supporting baseline assessments. Facilitating performance reviews, peer learning and continuing education.
COMMUNICATION
Ensure consistent communication, documentation, and knowledge sharing across all TRACE countries and within the global clinical trial network.
Focus areas: Preparing communication materials and updates. Supporting change-management processes. Coordinating multi-country learning and dissemination. Coordinating multi-country learning and dissemination.
FINANCIAL SUSTAINABILITY
Dedicated to supporting national health and research ethics committees in creating independent, long-term funding strategies and equitable cost-recovery fee models.
Focus areas: Mapping existing financing structures and gaps. Reviewing fee schedules and operational cost elements. Supporting budgeting, cost-analysis and planning. Supporting countries in developing sustainable financing options for NECs.
DIGITALIZATION
Enhances digital systems for Clinical Trial Application (CTA) processes across TRACE countries, aiming for more predictable, transparent, and efficient ethics and regulatory reviews, while improving data governance and system interoperability.
Focus areas: Assessing existing digital platforms and identifying system gaps. Supporting countries to develop User Requirements and Technical Specifications. Promoting interoperability between ethics and regulatory systems. Enhancing real-time tracking, workflow automation and transparency. Strengthening data security, data governance and compliance. Facilitating collaboration with harmonization, capacity building, and sustainability of sub-teams.