Master of Philosophy in Clinical Research Administration

Purpose

Rationale

Sub-Saharan Africa, and South Africa in particular, carries a significant burden of disease for which focused, cost-effective and sustainable interventions are needed. Improved healthcare structure is on the production and utilisation of new information generated through research. Clinical research can be the means for developing cost-effective and sustainable health interventions for addressing the extreme health challenges prevalent in South Africa. Successful research, in turn, is dependent on a relevant research agenda responsive to clearly defined health priorities, supportive research and clinical environments and above all, a high-level of research competence amongst the research team. While medical research and training occurs in many African Institutions, few institutions have sufficient resources and human capital for making a significant impact. A clear need exists for developing capacity and expertise for conducting clinical research, specifically the organisation and management aspects of conducting clinical trials.

The qualification focuses on the organisation and management of clinical trials for individuals involved in clinical research activities within academic institutions and the private sector, clinical research managers and coordinators, individuals involved in regulatory affairs and monitoring clinical trials.

Recognition of Prior Learning (RPL)

Learners who wish to be considered based on RPL (Recognition of Prior Learning) must have

• An approved undergraduate qualification.
• A minimum of two to three years experience in clinical research.
• Fluency in English, both written and spoken.
• Plans to pursue a career in clinical research.

Entry Requirements

The minimum entry requirement for this qualification is

• Relevant Bachelor Honours Degree, NQF Level 8.

And

• At least two years experience in clinical research and plans to pursue a career in clinical research.

This qualification consists of the following compulsory and elective modules at NQF Level 9 totalling 180 Credits

• Introduction to Clinical Research.
• Health and Development.
• Epidemiology.
• Organisation and Management.
• Information, Education and Communication.
• Research Methods for Health Professionals I.
• Good Clinical Practice.
• Research Methods for Health Professionals II.
• Biostatistics.
• The Process of Clinical Trials.
• Partnerships with Human Subjects.
• Introduction to Clinical Research Monitoring.
• Monitoring of Clinical Trials.
• Minor dissertation of 60 Credits.

1. Demonstrate critical understanding and knowledge of concepts and practices relating to clinical research administration.
2. Demonstrate knowledge, interpretation and application of the relevant ethical underpinnings and regulations to support good clinical practice.
3. Demonstrate knowledge for developing a framework for practising clinical research that includes key terminology, history and an overview of the processes associated with the clinical research.
4. Demonstrate the ability to access reliable sources of evidence and correctly interpret and apply this to clinical research practice.
5. Demonstrate the ability to apply good clinical practice principles for monitoring clinical trials.
6. Demonstrate an understanding of the rationale, considerations and strategies for effectively recruiting and retaining participants in clinical trials.
7. An ability to organise and manage clinical research, design a budget for based on resource needs and efficiently manage human resources.
8. Analyse and apply statistical concepts to population-based data using appropriate software; interpret, summarise and present statistical data.
9. Demonstrate knowledge and understanding of the key principles relating to teamwork and effective leadership in clinical trials.
10. Identify and solve problems in which responses demonstrate critical and creative thinking.
11. Work effectively with others as a member of a team, organisation and community.
12. Collect, analyse, organise and critically evaluate information.
13. Communicate effectively.
14. Demonstrate effective and appropriate use of science and technology.
15. Cultural sensitivity.
16. A capacity to manage learning tasks, to engage in self-evaluation and to learn independently for continuing professional development.

Associated Assessment Criteria for Exit Level Outcomes

• Conduct independent research in clinical research administration.
• Communicate verbally and orally with a range of audiences.
• Apply clinical research administration knowledge and research skills.
• Analyse and critique communications.
• Appreciate the ethical issues associated with research and knowledge production in clinical research administration.
• Challenge orthodoxies and redefine existing knowledge while demonstrating awareness of the nature of knowledge in the field.
• Summarise clearly, accurately and comprehensively all relevant aspects of an academic debate.
• Relate or apply existing knowledge in novel contexts.
• Adequate research problem formulation and development.
• Familiarity with and integration of the relevant and specialised literature that informs the research question.
• Application of relevant theoretical approaches and key research techniques at an advanced level.
• Systematic and sustained discussion and argumentation and integration of findings.
• Ability to address the normative issues that might attend the study.
• Appreciation of the methodological of the study.
• Use of the publication and style conventions of the discipline.

Integrated Assessment

Assessment of the coursework is continuous and consist of assignments. Learners achieve at least 50% in the coursework and for the dissertation. Assessment of research outcomes is by means of a dissertation of a word length stipulated by the faculty which normally consists of a substantial piece of work which demonstrates skills of independent research, response to supervisor's comments, mastery of the theoretical base and scholarly literature of a field of study.

The Institution has a system of external peer review and evaluation of each course. One of the aspects of the system is an evaluation of the standards and assessment practices of the department. The academic staff of the Institution use this in a manner which is consistent with the quality assurance system of the Institution.