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Australian clinical trial handbook, 2006

16 March 2006

The Australian Clinical Trial Handbook is a simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context.

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  • Foreword
  • Introduction
  • Good Clinical Practice principles in the Australian context
  • Getting Started: Questions to be answered
  • Trial Documentation: The Essentials
  • Human Research Ethics Committees
  • Investigators
  • Sponsors
  • Clinical trial medicinal products: Manufacture, Import, Export and Documentation
  • Managing Adverse Events and Adverse Drug Reactions
  • Clinical Trial Monitoring and Inspection
  • Clinical Trial Databases