Project: EDCTP-TDR TMA 2015 - Staples

Acronym SUES (Reference Number: TMA2015-1167)
Duration 01/05/2017 - 31/01/2019
Project Topic I obtained my Bachelor’s degree in medicine and surgery in 2008 from the University of the Free State in Bloemfontein, South Africa. After completing three years of government required employment and training and working as a medical officer in Internal Medicine I started work as a research clinician in late 2012. I am currently also enrolled at Stellenbosch University to do a MPhil In Transdisciplinary Health and Development Studies which I started in Jan 2016. While working as a research clinician in 2012 I was employed in the internal medicine department of McCord Hospital, Durban, South Africa. We worked in collaboration with K-RITH: KwaZulu-Natal Research Institute for TB and HIV to conduct various research projects in the field of Tuberculosis treatment. In Oct 2013, I was employed by THINK: TB and HIV Investigative Network in Durban, KwaZulu-Natal in South Africa. I initially worked as a sub-investigator working on TB Clinical Trials. At the end of 2013 I was promoted to Principal Investigator. I am currently still employed as the Principal Investigator of multiple phase 2 and 3 Trials at THINK These trials are conducted in collaboration with various Sponsors, such as TB Alliance, MRC UK, and the pharmaceutical industry. Since being employed I have taken on the role of PI for 5 research projects. I will be pursuing 12 months training at Julius Clinical, Zeist, The Netherlands with the aim of learning and understanding the operation of a scientific clinical research organization which will assist me in preparing and conducting future clinical trials and train junior researchers at the home organization. Training Objectives: • To familiarize oneself with the requirements for a phase III - IV clinical trial and other study designs such as pragmatic trials and real-world observational data. • To participate in proposal writing for grant applications. • To understand the clinical research organization’s request for proposal process. • To understand clinical trial budgeting and the bid grid. • To understand and participate in clinic trial design and protocol development. • To understand regulatory requirements of a clinical trial and prepare submissions to competent authorities. • To understand the site selection and site initiation process. • To understand good clinical laboratory practice. • To understand data management requirements. • To understand medical safety and pharmacovigilance. • To understand clinical trial monitoring. • To understand and participate in statistical analysis of clinical trial data. • To understand and participate in study report and manuscript preparation. Reintegration activities that will be implemented at the home organisation over 6 months: • Hold Regular Workshops/site meetings • Draw up guidelines for activities/processes learned • Revisit SOPS and review conditions and key requirements to render quality service • Conduct general research training with all staff • Identify staff that can play an ongoing supervisory role • Identify possible grants and apply if suitable one found • Start own research project that is currently in draft format
Project Results
(after finalisation)
Capacity development (Human resources): completion of placement at host institution Julius Clinical based in Zeist, The Netherlands: oWorked as a Scientific Officer, writing grant proposals and trial protocols as well as a sub-investigator in a large multi-site clinical trial-assisting in developing procedures for trial activities. oReceived certificates for completing courses in epidemiology, public health, introductory statistics, grant and proposal writing and the Basic course for clinical investigators (BROK) Capacity development (Human resources, Systems and Infrastructure): Implementation of transferable skills at home institution, THINK: TB and HIV Investigative Network, South Africa: oConducted various courses on: audit procedures, grant and research proposals and data protection. oAssisted in writing several grants and securing funding for THINK The fellow received the Chancellors distinguished alumni award from the University of the free State, South Africa, as recognition for being awarded the fellowship and the work in the field of TB research.
Network EDCTP2
Call EDCTP-TDR Clinical Research and Development Fellowships 2015

Project partner

Number Name Role Country
1 THINK TB & HIV Investigative Network Coordinator South Africa