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.
The TRACE Project defines four core workstreams designed to optimize clinical trial regulation and ethics across Africa. While the source material confirms that specific icons are intended to be included for each workstream on the project website, the specific visual designs of these icons are not detailed.
This involves Aligning SOPs and trial approval pathways with standards set by AVAREF (African Vaccine Regulatory Forum) and WHO best practices. The aim is to support legal review, stakeholder engagement, and achieve operational clarity across regulatory bodies
This objective is met through Training Institutional Review Boards (IRBs) and National Ethics Committees (NECs). It also supports accreditation schemes and benchmarking using ethics maturity models. The project aims to enhance the capacity of NECs, and IRBs.
The TRACE Project defines four core workstreams designed to optimize clinical trial regulation and ethics across Africa. While the source material confirms that specific icons are intended to be included for each workstream on the project website, the specific visual designs of these icons are not detailed.
This workstream focuses on creating or enhancing collaborative ethics review systems in which one authority or committee adopts or draws upon the assessment, decision, or recommendations of another competent body. Rather than repeating full reviews independently, participating institutions will leverage each other’s evaluations to streamline processes. The aim is to improve efficiency, consistency, and timeliness in clinical trial oversight while upholding rigorous standards for participant protection, ethical conduct, and data integrity.
This workstream focuses on Introducing workflow digitalization (such as RHInnO Ethics) and piloting AI-supported screening tools, including the development of an AI-based consent reviewer. The goal is to streamline approvals by favoring cloud-based platforms for interoperability and exploring blockchain for secure data authentication.
This addresses Financial Sustainability by strengthening clinical ethics system capacity in budgeting, reviewing existing and potential tiered fee structures, and supporting ethics review leadership in advocating for increased operational financing. The aim is to improve financial planning and reporting to drive the diversified resource generation necessary to ensure long-term clinical ethics system viability.
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.
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 project is implemented through five technical sub-teams that coordinate
activities across countries and ensure coherent, evidence-based progress.
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.
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.
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.
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.
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.
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.
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.
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.
At TRACE, our strategic direction is guided by a commitment to the United Nations Sustainable Development Goals (SDGs).
Our work directly contributes to SDG 3 (Good Health and Well-Being), SDG 9 (Industry, Innovation and Infrastructure), and SDG 17 (Partnerships for the Goals) — ensuring that health research and innovation serve as catalysts for equitable and sustainable progress across Africa and beyond.