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.
Adopting the Good Practice Process and employing a Clinical Trial Liaison Officer can reduce the clinical trial start-up timeframe by more than 100 days.
Good Practice Process Documents
- The Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (The Good Practice Process) (September 2016), (PDF, 2MB)
- Foreword from the CEO of NHMRC, Professor Anne Kelso AO (October 2016 ) (PDF,55KB)
- Streamlining the site assessment and authorisation of clinical trials – Final report (September 2016), (PDF, 1.7MB)
- Streamlining the site assessment and authorisation of clinical trials – results summary diagram (PDF, 87KB)