A clinical trial must have a sponsor ie the company, institution, organisation or individual that takes overall responsibility for the conduct of the trial and usually initiates, organises and supports the clinical trial. A sponsor may be an Australian commercial entity such as a pharmaceutical company or a not-for-profit organisation external to NSW Health such as a collaborative research group or university. For investigator-initiated clinical trials, the Local Health District may agree to act as the sponsor.
Each clinical trial conducted in a NSW Public Health Organisation and sponsored by an entity external to that organisation, must be governed by a Clinical Trial Research Agreement (CTRA).
Standard Medicines Australia Clinical Trial Research Agreements can be found here.
Standard Medical Technology Association of Australia (MTAA) Clinical Trial Research Agreements for device trials can be found here.