Background: The East African Community (EAC) has experienced significant increase in volume and complexity of clinical research, driven by epidemics of emerging and remerging infectious diseases such as HIV, Ebola and COVID-19, requiring a robust and pragmatic research regulatory framework. The overall goal of the SCALE-IT project is to strengthen scientific and ethics capacity in the EAC for high quality research protocol review, and oversight of research conduct, at international standards.

 The specific objectives are:

• To train National Research Regulatory Authority (NRRA) personnel, Research Ethics Committee (REC) members, researchers and clinicians on scientific and ethics review, and conduct of research with emerging and complex study designs including adaptive platform trials
• To train NRRA personnel and REC members on oversight and monitoring of clinical trials and
• To train NRRA personnel, REC and research administrators on personal effectiveness and leadership skills (PELS) to manage the increasingly complex research processes.

 Methodology: We are implementing this project within a consortium of research scientists from the six EAC partner states collaborating with the EU partner (EPICENTER), with the East African Health Research Commission (EAHRC) as the strong nucleus for coordination and dissemination of results. The project is hosted at the Infectious Diseases Institute (IDI), where, within a previous NIH funded program (5G11 TW011309-01) we developed training curricula for complex and emerging study designs, clinical trial monitoring and PELS, and trained REC members, researchers and REC administrators for 7 RECs in Uganda