Elements and Performance Criteria
- 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.
- 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.
- 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.
- 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.