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'.