Standard Operating Procedures for Clinical Trials

A key aim of NICM is to support high quality clinical research in complementary medicine in Australia and to ensure clinical trials are undertaken using Good Clinical Practice (GCP) standards (opens in a new window). Standardisation and improvements in quality will assist in building capacity for clinical research of complementary medicines within Australia.

To facilitate and improve the standardisation and quality of complementary medicine clinical research, NICM have developed Standard Operating Procedures (SOPs) for Clinical Trials. These SOPs take into account differences between clinical trials of pharmaceutical drugs (often single chemical entities), complex multi-component herbal interventions, individually tailored treatments, or those of highly interactive therapies such as acupuncture. 

The SOPs are written specifically for the Australian Clinical Trial environment with respect to the scientific and regulatory requirements for the conduct of clinical trials as detailed by the National Health and Medical Research Council (NHMRC) and Therapeutic Goods Authority (TGA), respectively. 

Currently under review, the clinical trials SOPs will be provided as a guide for research institution to adapt for their own individual use. 

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