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

PREAMBLE

This is the first edition of the Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa. The Guidelines are produced as a reference text for researchers, research sponsors, the general public and all those who have an interest in clinical trials research in South Africa. They provide guidance on minimum standards that are acceptable for conducting clinical trials in South Africa.

These guidelines have been compiled by a working group convened by the Director General of the Department of Health and has principally included representatives from the Department of Health, South African Drug Action Programme / World Health Organisation, Medical Research Council, the Medicines Control Council, Universities of Natal and the Witwatersrand and the AIDS Law Project. It has been compiled over a period of a year during which close interaction with major players in the South African research community has been critical.

The purpose of these guidelines is to provide South Africa with clearly articulated standards of good clinical practice in research that are also relevant to local realities and contexts.

These guidelines are closely related to the regulatory requirements of the Medicines Control Council and those of the National Department of Health’s legislative and regulatory framework. It is therefore critical that these guidelines are used by research ethics committees, researchers, trial participants, principal investigators of trials and sponsors alike so as to ensure a standardised and ethical approach to clinical trial activities in South Africa. The guidelines are applicable to both academic and contract clinical research.

The document is not exhaustive. It does however provide references of national and international texts to guide the reader to particular areas of interest. The document is unique in that it provides the first attempt at addressing issues related to clinical trial research in developing countries.

I believe these guidelines would contribute significantly to ensuring good health and promoting the health of South African citizens.

Dr ME Tshabalala-Msimang
Minister of Health

Date: 14 - 09 - 2000