Medical research involving human subjects is strictly controlled by the South African Health Products Regulatory Authority (SAHPRA); DOH and Ethics Committees. It is mandated that the research team be well versed with the International (ICH) and SA Good Clinical Practice guidelines. Each member of the team must be in possession of a valid, accredited GCP certificate.
In addition to the clinical personnel, a research team may include a number of support staff who recruit participants, take informed consents, counsel participants, transport participants, carry out laboratory procedures, capture data, etc. It is imperative that this category of staff understands the concept of research on human subjects, the guidelines that govern the conduct of this research, the roles of the study team and the importance of their role in the greater team.