Standard Operating Procedures for Clinical Trials

home_nicm_sops These Standard Operating Procedures (SOPs) are an initiative of the National Institute of Complementary Medicine's (NICM's) Collaborative Centre in Traditional Chinese Medicine (TCM). 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. The SOPs aim to facilitate and improve the standardisation and quality of clinical research in Traditional Chinese Medicine (herbal medicine and acupuncture) specifically, but can be easily adapted to other forms of complementary medicine. Standardisation and improvements in quality will assist in building capacity for clinical research of Traditional Chinese Medicines within Australia.

The SOPs take into account differences between clinical trials of pharmaceutical drugs (often single chemical entities), and those trials of complex multi-component herbal interventions, trials of individually tailored treatments, or those of highly interactive therapies such as acupuncture. The SOPs have been 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.

The SOPs are split into standalone files which include an introduction and 18 separate SOPs in PDF format. These SOPs are provided as a guide for others to customise and develop into a set of SOPs for their own individual research institutions. If using the NICM Clinical Trial SOPs in their original format you will need to print, enter the dates on which your SOPs will become effective, review and sign each SOP on behalf of your institution. Once operational, SOPs need to be reviewed and re-signed at least every 2 years.

Microsoft Office Word copies of the NICM Clinical Trial SOPs, including all templates can be requested from NICM, at Western Sydney University.

Request a copy of the Standard Operating Procedures for Clinical Trials.  

NICM SOPs for Clinical Trials in Complementary Medicine is under copyright© to the National Institute of Complementary Medicine (NICM) at the Western Sydney University, 2014 - and is not to be reproduced without the written consent of NICM (Email: nicm@westernsydney.edu.au; Telephone: +61 2 4620 3284; Fax: +61 2 4620 3291).