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'.

How to access a pdf document

Note for guidance on good clinical practice (CPMP/ICH/135/95 - Annotated with TGA comments) (pdf,136kb)

Contents

  • Introduction
  1. Glossary
  2. The principles of ICH GCP
  3. Institutional review board / independent ethics committee (IRB/IEC)
  4. Investigator
  5. Sponsor
  6. Clinical trial protocol and protocol amendment(s)
  7. Investigator's brochure
  8. Essential documents for the conduct of a clinical trial