GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA

ACKNOWLEDGEMENTS

The national guidelines have been developed to promote good practice and standards in the conduct of clinical trials in South Africa.

The process to develop these guidelines started in 1998 with the formation of a representative expert- writing group which by the end of 1998 had produced a conceptual framework. Subsequently, the process was taken forward by a small task team which has produced the final document.

The drafting team relied on their experiences and knowledge, experts’ advice, available literature, various country experiences and a variety of internationally accepted standards and guidelines. I hereby thank all those who granted us permission to refer to their documents.

I would like to express my sincere gratitude to all those who contributed to the drafting and writing of these guidelines. Thanks to the South African Drug Action Programme/World Health Organisation; Medicines Control Council; Medical Research Council; Universities of Natal and Witwatersrand; Lawyers for Human Rights; Directorate: Health Systems Research, Research Co-ordination and Epidemiology and Directorate: Pharmaceutical Services.

I would also like to sincerely thank all persons and groups that reviewed and made constructive comments and inputs to the guidelines including South African Institute for Medical Research; South African Pharmaceutical Clinical Research Association; Quintiles Clindepharm; MEDUNSA; Medical Research Council; Universities of Cape Town; Free State and Pretoria; Technikon Pretoria; ML Sultan Technikon; Technikon Witwatersrand; Indian Ocean Triangle Quinteles; WHO/EURO Programme for Pharmaceuticals; Health Professions Council of South Africa; Clinical Quality Concepts; WHO Collaborating Centre for Drug Policy; Rand Afrikaans University, SmithKline Beecham (Southern African Region) and all other contributors

Dr Ayanda Ntsaluba
Director-General: Department of Health