The CT-Luso project has published the Ethics and Regulatory Training Manual for Clinical Trials, designed to support the training of professionals involved in biomedical research, particularly in Portuguese-speaking African Countries (PALOP).
The publication is the outcome of the training course Ethical and Legal Requirements for the Development of Scientific and Clinical Research and brings together contributions from experts from Angola, Cabo Verde, Guinea-Bissau, Mozambique, São Tomé and Príncipe, and Portugal.
Organised into six modules, the manual covers the relationship between science and ethics; research integrity and good clinical practice; international bioethics guidelines; public health and infectious diseases; biobanks and responsible research; and regulatory affairs. It also includes perspectives on African contexts, QR codes providing access to the training presentations, and reference materials in Portuguese.
The publication forms part of CT-Luso’s efforts to strengthen the ethical and regulatory capacity required to conduct clinical trials in the PALOP countries, contributing to the protection of participants and the quality of research.