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 96.3 KB) has been established in addition to ethical review. An infographic (PDF 66.8 KB) 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's 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 on the National Health and Medical Research Council (NHMRC) webpage.
What is a Clinical Trial?
A clinical trial is a research investigation in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention* and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.
A clinical trial might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).
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' is used to refer to interventions, treatments and tests throughout this website.
This definition of a clinical trial is taken from the Australian Government's clinical trial webpage.
For assistance in determining whether your research project is a clinical trial, use this decision aid (PDF 74.8 KB)
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors is a joint guidance document that reflects the shared views of all state and territory Departments of Health, the Clinical Trials Project Reference Group (CTPRG), NHMRC and the Therapeutic Goods Administration (TGA). It is now available on NHMRC’s website.
It provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields.
The advice represents current thinking and best practice at the government level and will be reviewed and updated regularly to reflect changes in government policy, public health advice and the needs of those conducting and participating in clinical research in Australia.
The UTAS insurer for clinical trials has updated the policy to include a COVID-19 exclusion clause. Should a participant contract COVID-19/SARS-CoV-2 as a result of participating in a clinical trial (where the trial is not a Coronavirus-related trial that has been specifically accepted), they would not be covered by UTAS insurance for claims related to that disease.
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 that 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:
If non-synthetic therapeutic goods for administration to humans in a clinical trial are imported from overseas, they are considered a biosecurity risk material and require an import permit issued by the Department of Agriculture. The University of Tasmania has a valid permit for this commodity, which must be used whenever a consignment of therapeutics is imported.
If your trial involves the use of non-synthetic therapeutics, please refer to this fact sheet (PDF 45.7 KB) for information on how to obtain a copy of the UTAS permit.
The Clinical Trial Governance Toolkit 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.
Help and Support
For further information about Clinical Trials Governance, please contact the University’s Clinical Trial Governance team at Clinical.Trials@utas.edu.au.
The College of Health and Medicine (CHM) Research Hub 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.
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 participated in the NHMRC Good Practice Process for site assessment and authorisation of clinical trials.
Department of Health
If your proposed research or clinical trial requires the use of the Tasmanian publicly funded health service facilities, access to participants (patient and/or public health service employees) and/or their data (medical and personal records of information) and/or tissue collections held within the authority of the Tasmanian publicly funded health service, your proposed research or clinical trial must undergo a research governance review by the Department of Health, Research Governance Office.
Research governance can be defined as the ‘framework for effective oversight of research, such that it meets appropriate standards of safety and quality, safety, privacy and confidentiality, financial probity, legal and regulatory matters, risk management and monitoring arrangements’ which has ‘grown from an ancillary responsibility of the Human Research Ethics Committee (HREC) to the responsibility of the institution where the research is being conducted’. Source: National Health and Medical Research Council (NHMRC), Research Governance Handbook: Guidance for the national approach to single ethical review (2011)
Further Information and Support
The Department of Health (DoH), Research Governance Policy Framework (RGPF) and governance review forms are available on the DoH website: https://www.health.tas.gov.au/research. Contact the Department of Health Research Governance Office: firstname.lastname@example.org.
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
- CONSORT statement: Randomised Controlled Trial
- CONSORT statement: Pilot and feasibility trials
- NHMRC: Research Governance Handbook (PDF) (2011)
- NHMRC: Clinical Trial Reform
- TGA: Integrated Addendum to ICHGCP E6(R1): Guideline for Good Clinical Practice ICHGCP E6(R2) (2016)
- 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
- NSW Health: Early Phase Clinical Trial Framework for NSW (PDF) (2017)