Reference:
Department of Health. (2020). South African Good Clinical Practice: Clinical Trial Guidelines (3rd ed.). Pretoria, South Africa.
Summary:
The South African Good Clinical Practice (SA GCP) Guidelines, first established in 2006 and revised in 2020, provide a framework for conducting ethical and scientifically sound clinical trials within South Africa. Mandated by national health legislation, these guidelines aim to protect the rights, safety, and well-being of trial participants. Developed collaboratively by the Department of Health, the South African Health Products Regulatory Authority (SAHPRA), and the National Health Research Ethics Council (NHREC), the guidelines emphasise ethical principles, informed consent, and the management of vulnerable populations. They also align with international standards, including the International Council for Harmonisation’s Good Clinical Practice guidelines. The updated document encourages efficient trial design, oversight, and reporting to ensure high standards are maintained in clinical research, enhancing the credibility of trial outcomes and participant safety across various stages of health product development.