The development of a good clinical practice training model for use in South African clinical trials

Philosophiae Doctor - PhDMedicines for human use worldwide are generated in part through the conduct of clinical trials. This is done to ensure safety and efficacy. The involvement of human subjects in drug trials has raised concerns for the protection of human rights. As a consequence of the medical misadventures, the Declaration of Helsinki was formulated in 1964 and revised up to 2002. Today, the International Conference of Harmonization of Good Clinical Practice of 1996 guidelines are used worldwide (including South Africa) in the conduct of clinical trials. This study took place in South Africa. The objectives of the study were to first develop an instrument to be used in identifying the current good clinical practice knowledge and training needs of clinical researchers; secondly identify the knowledge level and training needs using the designed instrument and thirdly, based on the findings, develop a Good Clinical Practice training model so as to facilitate the achievement of quality standards for the conduct of clinical trials in South Africa.South Afric

OVERSIGHT AND SUPPORT ROLES OF LIMPOPO PROVINCIAL TREASURY

MM - P&DMThe state has a developmental mandate to the citizens of the country. This development is achieved through, among others, the allocation and distribution of resources in specific areas of developmental need. This allocation and distribution of resources is conducted through the budget process to various State departments and entities. However, financial management in state departments has, over the past years, and continues to be under immense scrutiny. This is as a result of various Auditor General‟s reports and media coverage on corruption cases. The Public Service Commission has also published damning reports of financial misconduct in State departments. The introduction and enactment of the Public Finance Management Act and the Municipal Finance Management Act tries to provide a legal framework to address these challenges faced with financial management within departments, municipalities and public entities. National and Provincial Treasuries are mandated by the two (2) Acts to monitor their implementation in public institutions. The Provincial Treasuries are also required to provide support to provincial public institutions for the effective implementation of the Acts. It is the effectiveness of these provincial treasuries that will go a long way in improving financial management in state departments. This study will look at the oversight/monitoring and support roles of Limpopo Provincial Treasury and determine the factors that lead to poor financial management oversight and support in Limpopo province. Trends in the Mosibudi Patricia Raphesu – Research Report MM (P&DM) PADM 5166 iii | P a g e current financial management oversight and support will also be determined through the study and recommendations will be made on strategies to be considered by Limpopo Provincial Treasury in improving these mandated roles