SAQA 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.
SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Facilitate community education for clinical research trials 
SAQA US ID UNIT STANDARD TITLE
260381  Facilitate community education for clinical research trials 
ORIGINATOR
SGB Ancillary Health Care 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 09 - Health Sciences and Social Services Promotive Health and Developmental Services 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 5  Level TBA: Pre-2009 was L5  10 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Reregistered  2018-07-01  2023-06-30  SAQA 06120/18 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2024-06-30   2027-06-30  

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 unit standard does not replace any other unit standard and is not replaced by any other unit standard. 

PURPOSE OF THE UNIT STANDARD 
The learner who is credited with this unit standard will be able to educate various members of various communities in a community setting with regard to the clinical research process Involved in the scientific process of developing and testing new medication.

The qualifying learner will be capable of:
  • Demonstrating fundamental understanding of science and research.
  • Demonstrating knowledge of ethical issues in clinical research.
  • Demonstrating knowledge of the vaccine research and development process.
  • Explaining the requirements for ensuring community involvement in clinical research. 

  • LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
    The following learning is assumed to be in place:
  • Communication skills at NQF Level 4.
  • Mathematical literacy at NQF Level 4.

    Competency in the following unit standards:
  • SAQA ID 114491: Educate and work closely with the community with regard to sexually transmitted infections (STIs) including Human Immune Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS).
  • SAQA ID 7384: Facilitate an adult learning events. 

  • UNIT STANDARD RANGE 
    N/A 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Demonstrate fundamental understanding of science and research. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Science and research are described in terms of the modern scientific approach. 

    ASSESSMENT CRITERION 2 
    Different types of clinical research are described in terms of fundamental research concepts. 
    ASSESSMENT CRITERION RANGE 
    Different types of clinical research include, but are not limited to:
  • Observational studies, experimental or intervention studies, sample size, placebo, randomisation, double-blind; single-blind, open labelled.
     

  • ASSESSMENT CRITERION 3 
    The stages in the research and development process are explained in terms of the clinical research process. 
    ASSESSMENT CRITERION RANGE 
    The stages of research and development processes include, but are not limited to:
  • Discovery, exploration, clinical studies, public implementation.
     

  • ASSESSMENT CRITERION 4 
    The phases of clinical trials are explained in terms of what is being tested, number of participants, participation criteria and length of time. 
    ASSESSMENT CRITERION RANGE 
    The phases include, but are not limited to:
  • Phase I, phase Ia, phase Ib, phase III, phase IV.
     

  • SPECIFIC OUTCOME 2 
    Demonstrate knowledge of ethical issues in clinical research. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The concept and development of a protocol is explained and demonstrated in terms of good clinical practice (GCP). 

    ASSESSMENT CRITERION 2 
    The legal, ethical and clinical guidelines that impact on protocol development, approval, running and monitoring of clinical trials are explained and demonstrated in terms of good clinical practice and current legal and ethical guidelines. 

    ASSESSMENT CRITERION 3 
    The roles and responsibilities of the groups and individuals involved in approving, running and monitoring clinical trials are explained and demonstrated in terms of good clinical practice. 

    ASSESSMENT CRITERION 4 
    Human rights, as defined in terms of the South African Constitution, are explained for purposes of clinical research, in terms of legislation, good clinical practice and ethical guidelines. 
    ASSESSMENT CRITERION RANGE 
    Human rights include, but are not limited to:
  • Informed consent, confidentiality, trial participant rights.
     

  • ASSESSMENT CRITERION 5 
    The concept of ethics and ethical requirements of research are explained in terms of clinical research in human beings. 

    ASSESSMENT CRITERION 6 
    The importance of obtaining informed consent from all target participants is explained in terms of ethical practice and guidelines. 

    SPECIFIC OUTCOME 3 
    Demonstrate knowledge of the vaccine research and development process. 
    OUTCOME RANGE 
    Where applicable, the assessment criteria are explained in terms of the currently recognised scientific body of knowledge. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The term 'vaccine' is explained in terms of what it is and how it works. 

    ASSESSMENT CRITERION 2 
    The effectiveness of vaccines in the prevention of infection is explained according to the broad principles of infection control. 

    ASSESSMENT CRITERION 3 
    The different vaccine designs are explained in terms of fundamental knowledge and understanding. 
    ASSESSMENT CRITERION RANGE 
    Vaccine designs include, but are not limited to:
  • Traditional designs (whole-killed/inactivated, live attenuated) or any current new approaches.
     

  • ASSESSMENT CRITERION 4 
    The stages in the vaccine research and development process are explained. 
    ASSESSMENT CRITERION RANGE 
    The stages in vaccine research and development include, but are not limited to:
  • Discovery, exploration, clinical studies, public implementation.
     

  • ASSESSMENT CRITERION 5 
    The phases of a vaccine clinical trial are explained in terms of what is being tested, number of participants, participation criteria and length of time. 
    ASSESSMENT CRITERION RANGE 
    The phases include, but are not limited to:
  • Phase I, phase IIa, phase II b, phase III, phase IV.
     

  • ASSESSMENT CRITERION 6 
    The research studies used for vaccine trials are explained in terms of fundamental knowledge and understanding of the various types of research designs. 
    ASSESSMENT CRITERION RANGE 
    Research includes, but is not limited to:
  • Observational, experimental, randomised, placebo controlled, double blind.
     

  • ASSESSMENT CRITERION 7 
    The structures involved in approving, running and monitoring vaccine clinical trials are explained in terms of good clinical practice. 
    ASSESSMENT CRITERION RANGE 
    The structures include, but are not limited to:
  • Regulatory body, Research Ethics Committee, Sponsor, Principal Investigator, Trial site team, Laboratory, Monitor, Auditor, Independent Data Monitoring Committee, Community Advisory Group.
     

  • ASSESSMENT CRITERION 8 
    Three local and/or global geographic locations of clinical vaccine trials are named. 

    SPECIFIC OUTCOME 4 
    Explain the requirements for ensuring community involvement in clinical research. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Community involvement in the clinical research and development process is explained in terms of relevant policies, legislation and good clinical practice guidelines. 

    ASSESSMENT CRITERION 2 
    The steps involved in facilitating community involvement are described in terms of the community entry process. 

    ASSESSMENT CRITERION 3 
    The level of community involvement is described in terms of the actions taken to facilitate active community involvement. 
    ASSESSMENT CRITERION RANGE 
    Facilitating community involvement includes, but is not limited to:
  • Creating awareness, gaining involvement in decision-making, gaining involvement in community health or research structures, trial participation, education, advocacy.
     


  • UNIT STANDARD ACCREDITATION AND MODERATION OPTIONS 
  • Anyone assessing a learner against this unit standard must be registered as an assessor with the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA.
  • Any institution offering learning that will enable achievement of this unit standard must be accredited as a provider through the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA.
  • Moderation of assessment will be overseen by the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA, according to the moderation guidelines and the agreed ETQA procedures. 

  • UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
  • Research methodologies and types.
  • Ethics in clinical studies.
  • Relevant health care legislation and regulations.
  • Methods for conducting vaccine trials. 

  • UNIT STANDARD DEVELOPMENTAL OUTCOME 
    N/A 

    UNIT STANDARD LINKAGES 
    N/A 


    Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO IDENTIFYING 
    Identifying and solving problems relating to the factors that affect clinical trials and the education of communities in clinical trials. 

    UNIT STANDARD CCFO WORKING 
    Working effectively with and supporting others as in all the activities required to conduct clinical trials effectively. 

    UNIT STANDARD CCFO ORGANISING 
    Organising and managing employees and their activities responsibly to ensure that clinical trials are run within agreed timeframes and reports kept according to required procedures. 

    UNIT STANDARD CCFO COMMUNICATING 
    Using visual and language skills in communicating with others including engaging the participation of the community and educating them on requirements for clinical trials. 

    UNIT STANDARD CCFO SCIENCE 
    Using science and technology effectively to gather information and data pertaining to clinical research trials for education purposes. 

    UNIT STANDARD CCFO DEMONSTRATING 
    Demonstrate an understanding of the world as a set of related systems by recognising that clinical research trials are not conducted in isolation and that a variety of factors can impact on the educational requirements surrounding the trials. 

    UNIT STANDARD ASSESSOR CRITERIA 
    N/A 

    REREGISTRATION HISTORY 
    As per the SAQA Board decision/s at that time, this unit standard was Reregistered in 2012; 2015. 

    UNIT STANDARD NOTES 
    Learning in this Unit Standard must form a part of a research programme conducted by an accredited health research institution, facility or establishment.

    It is strongly recommended that the learner educator is able to communicate in the language of the community and has knowledge of that community's specific cultural practices.

    Credit Justification:

    Total hours required by the learner to achieve the required outcomes:

    Activity; Hours; Credits:
  • Classroom learning/scenario/role play; 40 Hours; 4 Credits.
  • Case Studies; 30 Hours; 3 Credits.
  • Self directed learning/on-the-job learning; 30 Hours; 3 Credits.

    Total = 100 Hours; 10 Credits. 

  • QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Elective  64697   Further Education and Training Certificate: Community Health Work  Level 4  NQF Level 04  Reregistered  2023-06-30  HW SETA 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS UNIT STANDARD: 
    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.