The Wits Health Consortium was established as a legal entity through which the Faculty of Health Sciences can conduct its clinical trials. The WHC therefore provides the governance, legal framework, human resource management and grant management for CHRU. Administering grants, managing funded projects and ensuring regulatory compliance are other important services that WHC provides to CHRU.
Internal and external audits are performed by reputable accounting firms, produced in line with sponsor requirements. Strong internal controls mitigate risks and manage deadlines and budgets. Insurance is taken out on certain projects to protect the interests of all relevant parties. Project-specific audits to meet the requirements of specific donors or sponsors also take place.
CHRU also adheres to the requirements of the South African Health Products Regulatory Authority (SAHPRA) and Good Clinical Practice (GCP) requirements within SA and internationally, including the World Medical Association’s Declaration of Helsinki.GCP is the basis for CHRU’s clinical research and provides the guidance that is strictly adhered to before, during, and after a research study is undertaken.
All research is approved by the University of the Witwatersrand Human Research and Ethics Committee.