This workstream focuses on aligning Standard Operating Procedures (SOPs) and clinical trial approval pathways with international best practices, specifically those of the African Vaccine Regulatory Forum (AVAREF) and the World Health Organization (WHO). This involves supporting legal review, stakeholder engagement, and enhancing operational clarity across regulatory bodies. The goal is to harmonize national SOPs and regulatory pathways to improve transparency, predictability, and efficiency in trial review systems
This workstream aims to train and professionalize Institutional Review Boards (IRBs), National Ethics Committees (NECs), and regulatory staff. It supports accreditation schemes and utilizes ethics maturity models for benchmarking progress. A key milestone involves finalizing and adopting an IRB Certification Toolkit in the participating countries. The overall purpose is to build the required capacity and professionalize ethics committees.
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 introducing workflow digitalization to streamline regulatory and ethics systems. Initiatives include: • Workflow digitalization: Utilizing platforms like RHInnO Ethics. • AI-supported tools: Piloting AI-supported screening tools and developing an AI-based consent reviewer. • Regional transparency: Integrating dashboards for improved regional transparency. • Interoperability: Favoring cloud-based platforms for interoperability and cost savings. • Data security: Exploring blockchain technology for secure data authentication
This workstream addresses the long-term viability of ethics review systems. The focus is on building business cases for the sustained financing of these systems. This involves exploring hybrid government-donor models and ensuring alignment with national budgets to promote local ownership and resource models.