Note for guidance on good clinical practice
CPMP/ICH/135/95
7 July 2000
The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.
The TGA has adopted CPMP/ICH/135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements'.
Contents
- Introduction
- Glossary
- The principles of ICH GCP
- Institutional review board / independent ethics committee (IRB/IEC)
- Investigator
- Sponsor
- Clinical trial protocol and protocol amendment(s)
- Investigator's brochure
- Essential documents for the conduct of a clinical trial
Content last updated: Tuesday, 25 July 2000
Content last reviewed: Friday, 25 March 2011
Web page last updated: Friday, 25 March 2011
URL: http://www.tga.gov.au/industry/clinical-trials-note-ich13595.htm