It will be developed in 6 Portuguese-speaking countries: Angola, Cape Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe and Portugal, involving their respective National Ethics Authorities, National Regulatory Authorities, universities, research centres, national health institutes, in partnership with Portuguese institutions specialized in ethics, research regulation and clinical trials. It is a 40-month project, approved and funded by the EDCTP3 Programme (Partnership between Europe and Developing Countries for Clinical Trials) and with the support of the European Union.