The trial Sponsor is legally responsible for your trial.

What Is A Sponsor?

All clinical trials conducted in Australia must have a trial Sponsor that is an Australian entity. A trial Sponsor is occasionally an individual (e.g. medical practitioner) or more likely an organisation (e.g. pharmaceutical company, hospital, university, non-government organisation, cooperative research group) that takes overall responsibility for the initiation, management, financing, and provision of insurance and indemnity for a clinical trial.

The trial Sponsor carries the medico-legal responsibility for the trial’s conduct and is also responsible for:

• the quality and integrity of the clinical trial data.
• ensuring that appropriate approvals and authorisations are met and adhered to during the clinical trial.
• monitoring the trial for compliance with the protocol.
  
  

Identifying Your Sponsor

In many cases, an external organisation will be the Sponsor. If you are initiating the research project yourself, your employer may be the Sponsor. If not, then you must work with your employer to assess the suitability of the identified Sponsor and confirm the Sponsor’s commitment to your trial.

Who can help:

• Calvary Mater Newcastle Research Office
• Central Coast Local Health District Research Office
• Hunter New England Local Health District Research Office
• Mid North Coast Research and Knowledge Translation Unit
• HMRI Clinical Trials Unit
• University of New England Research Office
• University of Newcastle Research Office