Application
This unit of competency describes the skills and knowledge required to design and conduct a field-based research trial.
This unit applies to individuals who take personal responsibility and exercise autonomy in undertaking complex work. They analyse and synthesise information and exercise judgement to complete a range of advanced skilled activities.
No occupational licensing, legislative or certification requirements are known to apply to this unit at the time of publication.
Elements and Performance Criteria
Element | Performance criteria |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
1. Design the trial | 1.1 Identify problems and opportunities that support undertaking a trial and define the trial subject and projected outcomes as required by enterprise guidelines, market research, client requirements, cost analysis and cost benefits to the enterprise 1.2 Undertake research into available evidence to establish the performance criteria of the subject, product or treatment to be trialled and the trial design 1.3 Locate trial sites according to trial design requirements and enterprise capabilities and identify site factors and incorporate into the trial design 1.4 Identify and obtain approvals and permits required to conduct the trial 1.5 Establish data collection and recording specifications according to the trial design and follow proper conventions and controls to satisfy statistical audit requirements and eliminate variables according to sound clinical practice |
2. Prepare to conduct the trial | 2.1 Identify workplace health and safety hazards, assess risks and develop control measures, and cost and document in the trial design 2.2 Identify environmental implications associated with implementation of the trial and document in the trial design 2.3 Identify and cost materials, tools, equipment and machinery required for the trial and confirm availability with suppliers, contractors and appropriate personnel 2.4 Establish and prepare trial sites for implementation of the trial 2.5 Document detailed trial site plans, trial specifications and trial procedures clearly and comprehensively in the trial design |
3. Conduct the trial | 3.1 Undertake staged data collection throughout the course of the trial 3.2 Monitor trial implementation for accuracy, compliance to the trial design and out-of-specification procedures or events 3.3 Record all monitoring and trial data |
4. Assess practical application of trial outcome | 4.1 Undertake statistical auditing for the trial outcomes and follow proper conventions and controls to eliminate variables according to sound clinical practice 4.2 Draw conclusions from relevant information that are based on appropriate evidence and reasoned arguments 4.3 Assess trial outcomes for practical application, based on conclusions drawn from the trial |
Evidence of Performance
The candidate must be assessed on their ability to integrate and apply the performance requirements of this unit in a workplace setting. Performance must be demonstrated consistently over time and in a suitable range of contexts.
The candidate must provide evidence that they can:
establishing sound research parameters that enables achievable results
conducting research consistent with recognised scientific practice
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 of industry standard terminology
awareness of workplace health and safety in the context of own work
appropriate sustainability practices in the context of own work.
Evidence of Knowledge
The candidate must demonstrate knowledge of:
growth habits, physiological properties and taxonomic specification of animals and plants 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
bio-ethics (where animals are involved in the trial).
Assessment Conditions
Assessors must satisfy current standards for RTOs.
Foundation Skills
Foundation Skills essential to performance are explicit in the performance criteria of this unit of competency.
Range Statement
Sectors
Work (WRK)