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To improve clinical trial start-up times, we developed the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process).
Publication Data
Reference number
EH60
Current
To improve clinical trial start-up times, we worked with a wide range of stakeholders to develop the Good Practice Process.
The Good Practice Process aims to streamline the site assessment and site authorisation of clinical trials by:
- Outlining a set of principles and critical success factors for site assessment and site authorisation;
- Detailing a set of planning and preparation activities that can made a site more responsive to commencing clinical trials; and
- Proposing a streamlined workflow for site assessment and authorisation.
The Good Practice Process can be downloaded below.
The Good Practice Process was piloted in 16 clinical trial sites around Australia. The pilot program demonstrated that through adopting the Good Practice Process and employing a Clinical Trial Liaison Officer the clinical trial start-up timeframe can be reduced by approximately 100 days. A copy of the report from the pilots can be downloaded below.