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:
- Large multi-site collaborative group or investigator-initiated trials (IIT) where the Sponsor delegates some responsibilities to a Coordinating Principal Investigator (CPI), trial coordinating centre or contract research organisation (CRO).
- Institutions sponsoring an investigator-initiated trial or registry trial may delegate some Sponsor responsibilities to the lead Investigator. The lead Investigator then takes on the role of Sponsor-Investigator, the title reflects the dual role of both Sponsor and Investigator for the trial. Note some sponsoring institutions may use the term, Coordinating Principal Investigator to refer to this role. However, the toolkit uses the terms Sponsor-Investigator and Coordinating Principal Investigator to denote different meanings, see Glossary for definitions.
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.
Risk identification and assessment
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:
- Retain clear, accurate, secure and complete records of all clinical trials including clinical trial data and primary materials. As appropriate, allow access and reference to these by the regulator and interested parties
- Disseminate clinical trial findings responsibly, accurately and broadly. Where necessary, take action to correct the record in a timely manner
- Disclose and manage actual, potential or perceived conflicts of interest
- Ensure that authors of clinical trial outputs are all those, and only those, who have made a significant intellectual or scholarly contribution to the clinical trial and its output, and that they agree to be listed as an author
- Acknowledge those who have contributed to the clinical trial, and cite and acknowledge other relevant work appropriately and accurately
- Report suspected breaches of NHMRC: Australian Code for the Responsible Conduct of Research to the relevant institution and/or authority