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Elements and Performance Criteria

1. Design the trial
   • Problems and/or opportunities that support undertaking a trial are identified and the trial subject and projected outcomes are defined according to enterprise guidelines, market research, client requirements, cost analysis and cost benefits to the enterprise.
   • Research into available evidence is undertaken to establish the performance criteria of the subject, product or treatment to be trialled and the trial design.
   • Trial sites are located according to trial design requirements and enterprise capabilities, and site factors are identified and incorporated into the trial design.
   • Approvals and/or permits required to conduct the trial are identified and obtained.
   • Data collection and recording specifications are established according to the trial design, and proper conventions and controls are followed to satisfy statistical audit requirements and eliminate variables according to sound clinical practice.
2. Prepare to conduct the trial
   • Occupational Health and Safety (OHS) hazards associated with the implementation of the trial are identified, risks assessed and controls developed according to enterprise guidelines, costed and documented in the trial design.
   • Environmental implications associated with implementation of the trial are identified and documented in the trial design.
   • Materials, tools, equipment and machinery required for the trial are identified, costed, and availability confirmed with suppliers, contractors and appropriate personnel.
   • Trial sites are established and prepared for implementation of the trial according to the specifications of the trial design.
   • Detailed trial site plans, trial specifications and trial procedures are documented clearly and comprehensively in the trial design.
3. Conduct the trial
   • Staged data collection is undertaken throughout the course of the trial according to the specifications of the trial design.
   • Trial implementation is monitored for accuracy, compliance to the trial design and out-of-specification procedures or events.
   • All monitoring and trial data is recorded faithfully, promptly and accurately according to the specifications of the trial design.
4. Assess practical application of trial outcome
   • Statistical auditing is undertaken for the trial outcomes, and proper conventions and controls are followed to eliminate variables according to sound clinical practice.
   • Conclusions are drawn from relevant information and are based on appropriate evidence and reasoned arguments.
   • Trial outcomes are assessed for practical application, based on conclusions drawn from the trial and according to enterprise guidelines and industry best practice.

Required Skills

Required skills

research and evaluate information calculate the cost and spatial and logistical requirements of components of the trial enter analyse and organise data in a mathematically sound and accurately graphed charted or tabled representation consistent with the trial design comply with legislative requirements use literacy skills to fulfil job roles as required by the organisation The level of skill may range from reading and understanding documentation to completion of written reports use oral communication skillslanguage competence to fulfil the job role as specified by the organisation including questioning active listening asking for clarification negotiating solutions and responding to a range of views use interpersonal skills to work with others and relate to people from a range of cultural social and religious backgrounds and with a range of physical and mental abilities

Required knowledge

growth habits physiological properties and taxonomic specification of animalsplants involved in the trial physical and biochemical properties of products involved in the trial properties and current best practice application of treatments involved in the trial scientific and mathematical trialling data collection processing and analytical techniques and procedures auditing and reporting procedures the enterprise business and marketing plans enterprise work team management guidelines bioethics where animals are involved in the trial

Evidence Required

The evidence guide provides advice on assessment and must be read in conjunction with the performance criteria required skills and knowledge range statement and the Assessment Guidelines for the Training Package
Overview of assessment
Critical aspects for assessment and evidence required to demonstrate competency in this unit	The evidence required to demonstrate competency in this unit must be relevant to workplace operations and satisfy holistically all of the requirements of the performance criteria and required skills and knowledge and include achievement of the following establish sound research parameters that enables achievable results conduct research consistent with recognised scientific practice analysis and reporting reflects the scope and consequences of the project
Context of and specific resources for assessment	Competency requires the application of work practices under work conditions Selection and use of resources for some worksites may differ due to the regional or enterprise circumstances

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Range Statement

The range statement relates to the unit of competency as a whole.
Trial subjects may include:	individual animal or plant species or cultivars specified products, and treatments or applications whose performance or responses are measured in relation to defined performance criteria. Note: The involvement of animals in a research trial may be covered by duty of care provisions in Animal Welfare Acts and codes of practices dealing with animal ethics.

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