The Australian clinical trial handbook
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
The Australian clinical trial handbook (pdf,194kb)
Contents
- 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