All clinical trials conducted in Australia must have a trial Sponsor that is an Australian entity. An overseas company cannot be the Sponsor of a trial in Australia. Sponsors of trials under the CTN or CTX schemes may include individuals, companies, institutions, or organisations.
The trial Sponsor is responsible for the initiation, management and financing (or arranging the financing) of the trial and carries the medico-legal responsibility associated with its conduct. In addition, the Australian trial Sponsor is also the entity responsible for:
This also applies when a non-commercial trial Sponsor delegates duties to a Co-ordinating Principal Investigator (CPI).
The Sponsor may delegate some of its Good Clinical Practice (GCP) Sponsor responsibilities as appropriate to the set up of the trial, for example:
The Sponsor is also responsible for ensuring that appropriate approvals are obtained prior to the commencement of the clinical trial, that conditions of any approvals are adhered to during the course of the clinical trial and, ensures that the ethics principles of research merit and integrity, justice, beneficence and respect are applied to the conduct of clinical trials. Trial Sponsors ensure that a trial is appropriately monitored for compliance with the protocol.
The quality of information generated when clinical trials are conducted impacts on the future care of the Australian population. Before initiating a trial, the trial Sponsor should ensure that quality management systems are in place and that these systems are robust enough to fulfil all the requirements of the protocol and relevant regulatory requirements, including relevant state and territory legislation.
For example, when designing a trial, the principles of TGA: Guideline for Good Clinical Practice (GCP) requires trial Sponsors to use a multi-disciplinary team of qualified individuals (for example, biostatisticians, clinical pharmacologists, and physicians) as appropriate. This is required throughout all stages of the trial process, from designing the protocol and case report forms to analysing and preparing interim and final clinical trial reports.
When a health service organisation is an Institutional Sponsor of an IIT or registry trial, the governing body ensures that its overarching governance and quality management systems meet the organisation’s responsibilities as a Sponsor and a trial site.
When planning a clinical trial, trial Sponsors should have processes in place to ensure the risks associated with its conduct are identified and assessed so that adequate trial monitoring and management plans can be developed to mitigate risk that may adversely impact on trial quality or participant safety.
Trial Sponsors, or their delegate, are also required to: