Subscribe to the TRACE Newsletter
    Subscribe to the TRACE Newsletter

    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.

    • 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.

    • FINANCIAL SUSTAINABILITY

      Strengthens financial and operational viability of ethics systems.

      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.

    TRACE WORKSTREAMS

    TRACE project is implemented through five technical sub-teams that coordinate
    activities across countries and ensure coherent, evidence-based progress.

    • 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.

    • 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.

    • DIGITAL

      Supports the development and optimization of digital systems used for Clinical Trial Application (CTA) submission, review and approval processes across TRACE countries. Its goal is to make ethics and regulatory review processes more predictable, transparent, and efficient, while strengthening data governance and enabling interoperability between national systems.

      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.