Australian clinical trial handbook
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.
How to access a pdf or Word document
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- The Australian clinical trial handbook (pdf,382kb)
- The Australian clinical trial handbook (Microsoft Word,3.61Mb)
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
Content last updated: Thursday, 16 March 2006
Content last reviewed: Thursday, 16 March 2006
Web page last updated: Tuesday, 21 June 2011
URL: http://www.tga.gov.au/industry/clinical-trials-handbook.htm