Clinical Trial Governance
Clinical Trials are essential in improving the health and well-being of our community as they produce the best data available for healthcare decision making. Clinical trials can also provide direct benefit to participants by providing them with better treatments, therapies and diagnostic tests. To ensure clinical trials run at, and by, the University of Tasmania are of the highest quality, the Clinical Trial Governance Authorisation Process PDF (97KB) has been established in addition to ethical review. An infographic (PDF 67KB) of this process has been developed to support researchers.
Governance authorisation and ethical review may occur in parallel. The outcomes of the ethical review and governance review together make up the final documentation that is provided to the Deputy Vice-Chancellor (Research; DVCR). These documents collectively allow for consideration of all aspects of the clinical trial governance arrangements and will assist the DVCR decision on granting authorisation to conduct the clinical trial. Research cannot commence at a site until governance authorisation has been granted.
Information regarding the Australian Clinical Trials Environment and national initiatives is available at the National Health and Medical Research Council (NHMRC) webpage.
What is a Clinical Trial?
The World Health Organization (WHO) definition for a clinical trial is
‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.
Clinical trial interventions include but are not restricted to:
- experimental drugs
- cells and other biological products
- medical devices
- surgical and other medical treatments and procedures
- psychotherapeutic and behavioural therapies
- health service changes
- preventive care strategies and
- educational interventions.
Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
*The word 'intervention' will be used to refer to interventions, treatments and tests throughout this website.
For assistance in determining whether your research project is a clinical trial, use this simple decision aid (PDF 71KB)
Applying for Clinical Trial Authorisation at the University of Tasmania
If your project is a clinical trial, the next step is to determine what role the University of Tasmania is playing.
A clinical trial sponsor is defined as the organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
The University of Tasmania can play one of four roles in a clinical trial:
The Clinical Trial Governance Elements webpage includes information on Good Clinical Practice training, Data Management and more. It also has a number of templates to support the conduct of clinical trials at the University of Tasmania.
If you are unsure, or have any questions about the information provided here please contact the Clinical Trial Governance Coordinator at firstname.lastname@example.org or (03) 6226 1956. Any amendments that may affect the ongoing governance authorisation of the clinical trial, for example adding new sites when the University is the sponsor, must be communicated to the Clinical Trial Governance Coordinator via email@example.com.
Help and Support
For further information about Clinical Trials Governance, please contact the University’s Clinical Trial Governance Coordinator at firstname.lastname@example.org or (03) 6226 1956.
The Clinical Trial Governance Coordinator is responsible for assessing the site-specific (governance) aspects of clinical trials run at, or by, the University of Tasmania and making a recommendation to the Deputy Vice-Chancellor (Research) as to whether the trial should be authorised. The Clinical Trial Governance Coordinator is able to assist researchers and industry sponsors in the design, initiation and conduct of clinical trials.
A state-wide Clinical Trials Governance Steering Committee is responsible for developing effective workflows between the Department of Health and Human Services, the Tasmanian Health Service and the University. The Committee is participating in the NHMRC Good Practice Process for site assessment and authorisation of clinical trials.
If you are conducting the trial at a Tasmanian Health Service (THS) site, or a Department of Health and Human Services (DHHS) site/clinic you will need to seek governance authorisation from each site. Contact your site for information about their site specific processes.
- DHHS Clinical Governance (DHHS intranet)
- THS Southern Region (DHHS intranet) or email: email@example.com
- THS Southern Region Allied Health (DHHS intranet)
- THS Southern Region Nursing (DHHS intranet)
- THS North West Region (DHHS intranet)
Useful links and resources
- University of Tasmania Research Integrity and Ethics training
- Australian Government: Australian Clinical Trials – for researchers
- Australian Government: Resources for Clinical Trials in Australia
- Australian Government: Clinical Trials Toolkit
- NHMRC: Research Governance Handbook (2011)
- NHMRC: Clinical Trial initiatives
- TGA: Note for Guidance on Good Clinical Practice CPMP/ICH/135/95 (2000)
- NIH Clinical Trial Protocol template
- SPIRIT Protocol template and checklist
- PRAXIS training: workshops include Clinical Trial Essentials
- ARCS Australia Professional Development in Therapeutics
- TRAJAN: Optimising clinical trials in a commercial context
- Office of the Gene Technology Regulator: Guidance on the regulation of clinical trials involving Genetically Modified Organisms