Trial Registration

All clinical trials involving Australian investigators or participants, in all areas of health and testing all forms of interventions should be registered in the Australian New Zealand Clinical Trials Registry (ANZCTR). ANZCTR is a national on-line register of clinical trials being undertaken in Australia.

Studies that meet the International Committee of Medical Journal Editors (ICMJE) definition of a clinical trial should be registered. That is, any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include any intervention used to modify a health outcome and include drugs, surgical procedures, devices, behavioural treatments, etc. If in any doubt whether to register or not, registration is recommended.

Responsibility for registration lies with the Sponsor. A Sponsor is defined by the Australian regulatory bodies - the National Health and Medical Research Council (NHMRC) and the Therapeutic Goods Administration (TGA) - as "an individual, company or institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial". It is the Sponsor’s responsibility to ensure that the information submitted is accurate and up-to-date. For full details see the ANZCTR website: http://www.anzctr.org.au/