Project 3

Early Phase Trials Best Practice Toolkit

Timeline: Q1, 2019 –  Q4, 2019.

Issue:  There is currently no single source of best practice outlining expectations for the conduct of Early Phase clinical trials in Australia.

Purpose:  Increased assurance on safety and performance of Early Phase clinical trials in Australia

Objectives:  ID broadly, summarise & test recommendations for best practice conduct of Early Phase clinical trials.


  • National & international environment scan & literature review.
  • Qualitative analysis: Survey &/or interview relevant stakeholders.
  • Host Expert Meeting to define Australian Best Practice to define minimum site standards.
  • Road test minimum standards at a variety of sites.


  • Literature review providing summary of international guidance.
  • Best practice guidance recommendations.


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