Elements and Performance Criteria
- Design the trial
- 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
- Undertake research into available evidence to establish the performance criteria of the subject, product or treatment to be trialled and the trial design
- Locate trial sites according to trial design requirements and enterprise capabilities and identify site factors and incorporate into the trial design
- Identify and obtain approvals and permits required to conduct the trial
- 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
- Prepare to conduct the trial
- Identify workplace health and safety hazards, assess risks and develop control measures, and cost and document in the trial design
- Identify environmental implications associated with implementation of the trial and document in the trial design
- Identify and cost materials, tools, equipment and machinery required for the trial and confirm availability with suppliers, contractors and appropriate personnel
- Establish and prepare trial sites for implementation of the trial
- Document detailed trial site plans, trial specifications and trial procedures clearly and comprehensively in the trial design
- Conduct the trial
- Assess practical application of trial outcome
- Undertake statistical auditing for the trial outcomes and follow proper conventions and controls to eliminate variables according to sound clinical practice
- Draw conclusions from relevant information that are based on appropriate evidence and reasoned arguments
- Assess trial outcomes for practical application, based on conclusions drawn from the trial