Medicines 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.

Medicines 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.

Submitted in partial compliance with the requirements for the Master’s Degree in Technology: Chiropractic, Durban University of Technology, Durban, South Africa, 2016. / Background: Iliotibial band friction syndrome is a common dysfunction seen in athletes. Athletes develop biomechanical changes yet still continue with their sport. However, this syndrome limits their ability to participate at peak performance. This study determined which participants benefitted in terms of biomechanical and clinical outcomes in one of four groups: ankle joint, superior tibio-fibular joint, sacroiliac joint or a combination manipulation group (which contained any two of the three joint restrictions). Methods: This Durban University of Technology Institutional Research and Ethics Committee approved prospective clinical trial, utilised stratified sampling, with 48 participants across four groups: ankle (14); superior tibio-fibular (11), sacroiliac (12) and combination (11). The participants underwent six treatments in three weeks. Data collection occurred before consultations one, three, five and seven. The data included primary measures of the knee score questionnaire (KSQ), the algometer, the visual analogue scale (VAS) and the secondary measures of the Feiss line, the heel leg alignment, bilateral leg length, Q angle and tibio-femoral angle. All data was computed utilising the ANOVA testing, with a p-value <0.05 being significant and a 95% confidence interval. Pearson’s correlations were completed for intragroup associations between primary and secondary outcome measures. Results: The intragroup analysis revealed that all groups had significant changes in the KSQ and VAS, with the exception of the sacroiliac joint manipulation group (KSQ outcome not significant). Intergroup analysis revealed no differences between the groups with the exception of the combination group, which showed a significant increase in the tibio-femoral angle. Most commonly, the Pearson’s correlation revealed that changes in leg length were related to differences in primary outcome measures, irrespective of the group being tested. Conclusion: The outcomes of this study indicated that manipulation of the distal kinematic chain improved alignment and clinical outcomes to a greater degree than manipulating proximal restrictions. It is suggested with caution (due to limited sample size) that patients should first have their distal kinematic chain manipulated before more proximal joints are manipulated to achieve better outcomes. / M

Abstract in English and Afrikaans / The clinical research enterprise is an industry in crisis due to the challenges investigators and sites experience to stay viable. Clinical researchers might therefore also become an “endangered species”. The purpose of this study was to gain an understanding of early career research investigators’ experience of clinical research. A generic, exploratory, descriptive and contextual qualitative design was used. Fourteen participants were recruited and interviewed face-to-face from three different clinical research sites in the Gauteng. Data were analysed thematically and cyclically. Findings indicated that early career investigators entered the clinical research “maze” for various reasons and levels of preparedness. As they explored the maze, early career investigators found their way into a labyrinth, all the while making discoveries about the clinical environment and their own desires. They finally reached a point where they needed to move beyond the centre of the labyrinth and ask ‘Quo Vadis’ (where are we going to)? / Die kliniese navorsingsbedryf is ‘n industrie in krises weens die uitdagings wat ondersoekers en navorsingsinstansies beleef om lewensvatbaar te bly. Kliniese navorsers mag daarom ook ‘n ‘bedreigde spesie’ word. Die doel van die studie was om die belewenis van vroeë beroepsnavorsingsondersoekers in kliniese navorsing te verstaan. ‘n Generiese, verkennende, beskrywende en kontekstuele kwalitatiewe ontwerp is gebruik. Veertien deelnemers van drie verskillende kliniese navorsingsinstansies in Gauteng het deelgeneem aan een-tot-een onderhoude. Data is tematies en siklies geanaliseer. Bevindinge het aangedui dat vroeë beroepsnavorsingsondersoekers die kliniese navorsingsdoolhof betree vir verskillende redes en vlakke van gereedheid. Soos wat hulle die doolhof verken het, het vroeë beroepsnavorsingsondersoekers hulle weg in die labirint gevind, terwyl hulle die kliniese omgewing en hul eie wense ontdek het. Hulle het uiteindelik ‘n punt bereik waar hulle verby die middel van die labirint moes beweeg en hulself afvra: “Quo Vadis” (waarheen gaan ons)? / Health Studies / M.A. (Nursing Science)