Note for guidance on good clinical practice
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'.
- The principles of ICH GCP
- Institutional review board / independent ethics committee (IRB/IEC)
- Clinical trial protocol and protocol amendment(s)
- Investigator's brochure
- Essential documents for the conduct of a clinical trial