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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD THAT HAS PASSED THE END DATE: 

Utilise applicable clinical research findings of pharmaceutical products during a sales visit 
SAQA US ID UNIT STANDARD TITLE
259361  Utilise applicable clinical research findings of pharmaceutical products during a sales visit 
ORIGINATOR
SGB Pharmacy 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 09 - Health Sciences and Social Services Curative Health 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 5  Level TBA: Pre-2009 was L5  8 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Passed the End Date -
Status was "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 
Individuals credited with this unit standard will have an understanding of clinical research terms, concepts, principles and methods. 'Pharmaceutical' includes medicines, medical products, medical devices, scheduled substances, veterinary medicines, products and devices, in accordance with the relevant current legislation. This unit standard is aimed at individuals entering the pharmaceutical sales field.

Learners achieving this unit standard will be able to:
  • Explain the principles of clinical research methodology.
  • Interpret clinical study results and reports.
  • Communicate findings effectively. 
    		•

    LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
  • Mathematical Skills at NQF Level 4.
  • Communication Skills at NQF Level 4.

    Recognition of Prior Learning:

    A learner may be accredited against this unit standard in terms of recognition of prior learning, based on accreditable evidence of competence in all the required specific outcomes of this, and all the unit standards specified under the heading Learning Assumed to be in Place; and in accordance with the requirements of the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA. 
    		•

    UNIT STANDARD RANGE 
    All clinical studies used for the purpose of this unit standard must have been carried out according to the applicable international and national accepted guidelines. 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Explain the principles of clinical research methodology. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    Clinical studies are described in terms of their purpose and principles in order to demonstrate the effective, safe and appropriate use of the particular product. 

    ASSESSMENT CRITERION 2 
    Clinical studies are described according to the context in which they are carried out. 

    SPECIFIC OUTCOME 2 
    Interpret clinical study results and reports. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    The methods used for the analysing of clinical study results are explained to identify a method appropriate for given circumstances. 

    ASSESSMENT CRITERION 2 
    The identified method for analysis is used to interpret the results of the specific study and suitable methods for given circumstances are identified. 

    ASSESSMENT CRITERION 3 
    The outcomes of the analysis are used to design a strategy which highlights the specific advantages of the given product in a fair and ethical way. 

    SPECIFIC OUTCOME 3 
    Communicate the findings effectively. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    The clinical study results are accurately, fairly and ethically paraphrased in a report. 

    ASSESSMENT CRITERION 2 
    The paraphrased and related information is communicated to the client, in order to demonstrate the effective and appropriate use of the particular product such that the patient receives the best treatment option available. 


    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.
  • Moderators must be accredited and allocated by the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA. 
    		•

    UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
    The concepts:
  • Pharmaceutical.
  • Stakeholders.
  • Product characteristics.
  • Dosage forms.
  • Critical aspects.
  • Quality assurance.
  • Appropriately authorised person. 
    		•

    UNIT STANDARD DEVELOPMENTAL OUTCOME 
    N/A 

    UNIT STANDARD LINKAGES 
    N/A 


    Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO WORKING 
    Working with others in a team is demonstrated in the interpreting and communicating of clinical study results accurately, fairly and ethically. 

    UNIT STANDARD CCFO COLLECTING 
    Collating and evaluating information are demonstrated in the interpretation of clinical study results and reports accurately, fairly and ethically. 

    UNIT STANDARD CCFO COMMUNICATING 
    Communicating effectively is demonstrated in presenting the findings of clinical study results accurately, fairly and ethically. 

    UNIT STANDARD CCFO SCIENCE 
    Using science and technology are demonstrated in the accessing and interpretation of clinical study results and reports. 

    UNIT STANDARD CCFO DEMONSTRATING 
    Understanding the world as a set of related systems is demonstrated as they apply to clinical study results. 

    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 
    Integrated Assessment:

    Assessment will be based on techniques such as:
  • Written assessment.
  • Portfolio of evidence demonstrating understanding.
  • Simulated scenarios.
  • Peer assessment.

    The learner should demonstrate the ability to explain concepts accurately, fairly and ethically in a clear and understandable manner in language that is appropriate for the target audience - most often medical doctors.

    It is strongly recommended that this unit standard should only be undertaken after all the other Core unit standards have been completed.

    Credit Justification:
  • Classroom Learning, 40 hours, 4 credits
  • Self Study, 30 hours, 3 credits
  • Resource centre utilisation, 10 hours, 1 credit 
    		•

    QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Core  63969   National Certificate: Pharmaceutical Sales Representation  Level 5  Level TBA: Pre-2009 was L5  Passed the End Date -
    Status was "Reregistered"     		 2023-06-30  CHIETA 


    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.