Guidelines for Good Practice in the conduct of Clinical Trials in South Africa

• Date: December 09, 2009
• Source: www.doh.gov.za

Clinical trials on Human participants needs strict vigilance and is conducted under high standards of quality assurance. Quality assurance of clinical trials in South Africa is achieved at a number of levels, through monitoring, audits and inspections. Clinical trials are a joint responsibility of the sponsor and the investigators. A proper comunication channel has to be established between the sponsor and the invetigators at every stage of the trial. Regular audits are necessary to ensure proper processes are followed and all regulatory compliances are considered. Independent regulatory authority may conduct announced or unannounced inspections at any stage of the trial to review the competency of the clinical trial site.