Elements and Performance Criteria
- Determine purpose of trial
- Analyse documentation available on trial
- Consult with trial proponent and other stakeholders
- Define purposes of trial
- Confirm trial purpose with all stakeholders
- Identify health, safety and environment (HSE) and other risks from the trial
- Negotiate conflicts in trial purpose
- Promulgate agreed trial purpose
- Determine trial metrics
- Determine information required from trial
- Identify relevant data which is available or which could be made available
- Identify gaps in data and negotiate suitable proxies for data
- Arrange for data to be collected
- Ensure there is appropriate capability for required data manipulation
- Ensure the availability of appropriate procedures/protocols for collection and manipulation of data
- Coordinate trial
- Develop procedures required for trial
- Check procedures to ensure appropriate risk management is included
- Draft trial plans
- Confirm trial plans with all relevant personnel
- Negotiate conflicts as required
- Promulgate agreed trial plans
- Arrange for the required resources to be available when required by plan
- Coordinate the implementation of the trial plan
- Recognise indications of developing problems and take appropriate action
- Monitor the progress to plan and take appropriate action to achieve required outcomes
- Conclude trial when appropriate
- Interpret trial results
- Ensure all data is collated and manipulated as required
- Interpret data in terms of trial purpose
- Analyse data for unexpected outcomes
- Determine trial outcomes
- Draft trial report, including recommendations
- Discuss report with relevant stakeholders as appropriate
- Publish final report and recommendations as required