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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED QUALIFICATION: 

Master of Philosophy in Clinical Research Administration 
SAQA QUAL ID QUALIFICATION TITLE
104785  Master of Philosophy in Clinical Research Administration 
ORIGINATOR
University of Cape Town 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY NQF SUB-FRAMEWORK
-   HEQSF - Higher Education Qualifications Sub-framework 
QUALIFICATION TYPE FIELD SUBFIELD
Master's Degree  Field 09 - Health Sciences and Social Services  Promotive Health and Developmental Services 
ABET BAND MINIMUM CREDITS PRE-2009 NQF LEVEL NQF LEVEL QUAL CLASS
Undefined  180  Not Applicable  NQF Level 09  Regular-Provider-ELOAC 
REGISTRATION STATUS SAQA DECISION NUMBER REGISTRATION START DATE REGISTRATION END DATE
Reregistered  EXCO 0821/24  2021-07-01  2027-06-30 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2028-06-30   2031-06-30  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This qualification does not replace any other qualification and is not replaced by any other qualification. 

PURPOSE AND RATIONALE OF THE QUALIFICATION 
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. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
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. 
    		•

    RECOGNISE PREVIOUS LEARNING? 
    Y 

    QUALIFICATION RULES 
    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. 
    		•

    EXIT LEVEL OUTCOMES 
    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 
    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. 
    		•

    INTERNATIONAL COMPARABILITY 
    This qualification is comparable to other similar qualifications around the world offered at Harvard and GW School of Medicine and Health Sciences, with regards to outcomes and assessment criteria, degree of difficulty and notional learning time. The standard is assured, among other things, by a requirement for assessment by external examiners who hold a university academic position, and where at least one is outside of South Africa. 

    ARTICULATION OPTIONS 
    This qualification allows for both vertical and horizontal articulation.

    Horizontal Articulation:
  • Master of Philosophy, NQF Level 9.

    Vertical Articulation:
  • Doctor of Philosophy, NQF Level 10. 
    		•

    MODERATION OPTIONS 
    N/A 

    CRITERIA FOR THE REGISTRATION OF ASSESSORS 
    N/A 

    NOTES 
    N/A 

    LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION: 
     
    NONE 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 


    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.