Clinical trials involving UWA
The University of Western Australia engages in clinical trials of new medicines and medical devices in several capacities: as sponsor; providing chief investigator and co-investigators; ethics review; site administration; and as a collaborator on single and multi-site trials with hospitals and other research institutes.
Clinical trial activities are regulated primarily by the Commonwealth's Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC).
This page serves as a home for information about clinical trials, how to comply with clinical trial regulation and other requirements, including contractual requirements, as well as some best practice guides. Please note that this page focuses on clinical trials that require TGA clinical trial notifications – i.e. trials that involve an intervention, in particular trials that test a new drug or device, or that test an existing drug or device for a new purpose. Yet some of the information contained here may also be relevant to observational trials.
Commonly used terms
Clinical Trial - The World Health Organisation (WHO) defines clinical trials as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes”.
Sponsor – the Sponsor is responsible for the oversight of the study, and may in some instances administer funds for the study. The Sponsor is also required to fulfil all regulatory requirements of the TGA. The Sponsor must be an Australian entity for TGA purposes. The responsibilities of a Sponsor are set out in section 5 of the TGA endorsed Guidance on Good Clinical Practice.
Local Sponsor – the Local Sponsor is responsible for the conduct of the Study in Australia.
Chief Investigator (or Principal Investigator) – the person who has the overall day-to day responsibility for managing the Study.
Institution – through the Principal Investigator, is responsible for the conduct of the Study at the Study Sites which is/are under the control of the Institution.
Developing clinical trial funding applications
Developing clinical trials, including drafting applications for clinical trial grants, is a highly specialised task. There are a range of people at UWA, and more broadly in WA and in Australia, who can provide expert advice. The Research Grants and Contracts Office can provide names of researchers who have experience developing and running clinical trials, as can your Faculty Research Development Advisor.
A key resource available to UWA researchers is the WA Health Translation Network (WAHTN). The WAHTN, including via their Clinical Trials and Data Centre and enabling platforms for the Research Education and Training Program (RETP) and Research Governance and Ethics (WA), can provide advice in good clinical practice, research ethics and governance requirements clinical trial study design (including novel designs), clinical trial conduct, data management, data-linkage, analytical techniques for clinical trial datasets, bio-repository techniques and clinical registry datasets. The WAHTN is keen to attract more clinical trial funding to WA and their staff are very happy to work with researches preparing grant applications.
There are also a range of other available resources, including a range of specialist clinical trial entities, including Linear and the Institute for Respiratory Health Clinical Trials Unit, both of which are run out of the Harry Perkins Institute of Medical Research.
How to request UWA act as Sponsor, and to notify your trial to the TGA
Acting as sponsor for a clinical trial carries several responsibilities. These are explained in Chapter 5 of Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2), as annotated by the Therapeutic Goods Administration. UWA is prepared to act as clinical trial sponsor for some trials, usually those assessed as low-risk and conducted in or near Perth. To have UWA accept the sponsor role you need to do the following:
- Formally request acceptance of the sponsor role to the University’s clinical trial contact (below). Include with your request: a copy of the trail protocol, the ethics approval letter, evidence that you have notified the University’s insurer of your trial, trial documents referred to in sections 7 and 8 of the current GCP guidelines. There is a checklist you can use for this here. The University will conduct a governance and risk review of these documents to decide if we are able to accept the responsibility of sponsor.
- A completed UWA Sponsor Request and Clinical Trials Notification form – UWA will use this information to perform a governance review and, if the University accepts the role of sponsor, will lodge a Clinical Trial Notification (CTN) at the Therapeutic Goods Administration (TGA) if a CTN is required.
- The University usually cannot take Sponsor responsibilities for higher risk intervention studies, or multi-site trails where some sites are outside of the greater Perth area. In such cases you project will need to identify a professional clinical trials contract research organisation (CRO) to act as sponsor.
When we lodge a CTN we need to know that the people being named in the form have provided consent:
- HREC: If UWA's Human Research Ethics Committee is providing the ethical review of the project, then we will obtain their approval letter; if a different HREC is doing the ethical review, please forward a copy of their approval letter.
- CI: The form you send us implies that the named Chief Investigator is willing to be listed as CI.
- Site: Please forward an email from the person responsible for the trial site which makes it clear they are willing to be listed as site manager on the CTN; if there is a separate person authorising the site please provide that too.
For each person, we require: institution, name, role, phone, and email address.
While the CTN to the TGA is the only mandatory registration, it’s strongly recommended that you also list the trial with the Australia & New Zealand Clinical Trial Registry (ANZCTR).
In addition, check your funding conditions, as they may specify a requirement for additional registrations. This is likely to be the case with international funding.
Make sure the trial is insured
While UWA’s insurance policy will cover clinical trials, our insurance partner, Gallagher, must be notified of individual studies to ensure they are covered. Notification can be provided via the Clinical Trial Insurance Notification form and sent to UWA insurance: [email protected]. The chief investigator should ensure that this is done as soon as possible after receiving Ethics approval. UWA’s insurance partner will advise of any additional insurance requirements or additional premiums. All insurance queries should be directed to the insurance partner: [email protected]; 08 6250 8444.
Obtaining (hospital) Human Research Ethics Committee approvals
Most non-university study sites, including most WA hospitals, do not accept HREC approvals from universities for studies involving hospital patients. HREC approvals will instead need to be obtained from the study site HREC.
Hospital HRECs will sometimes grant ethics approval to work in all of the hospitals under their jurisdiction. Sometimes they will provide it only for one hospital, or a sub-set of hospitals, in their jurisdiction. It is vital that you take careful note of which hospitals you have approval to work with, and obtain additional review and approval from any other hospital sites you plan to work with.
The WA Department of Health supports single ethical review, and Western Australia is a party to the National Mutual Acceptance arrangements, whereby in some instances a single HREC review will cover multiple Australian trial sites.
Requests for HREC approval to access WA public hospital patients can be sought via the WA Department of Health online Research Governance Service.
Please be aware that projects that will include Aboriginal people or communities may require approval from the Western Australian Aboriginal Health Ethics Committee.
Please also be aware that for commercially sponsored trials the hospital may charge fees for scientific, ethical and governance reviews.
UWA will normally accept an approval from any NHMRC registered HREC, without requiring an additional University review, (as permitted by National Statement). UWA will also in some cases recognise ethics approvals from Institutional Review Boards from other countries, depending on the risk level and the other country’s adoption of the Declaration of Helsinki. However, in all instances, a project team should not assume automatic recognition of a non-UWA HREC approval. Please contact our Human Ethics office if there is any doubt ([email protected]; 6488-4703).
If your research project protocol includes a hospital and at a UWA site, please make it clear in your HREC application that you are asking for the review to include the UWA site.
Information on obtaining HREC approval from other state public hospitals can be found here:
Obtaining hospital governance approvals
In addition to obtaining HREC approval, most hospital sites will also require that governance approval ("Site Specific Approval") is obtained, prior to the study commencing at a hospital site.
For the WA public hospitals, governance approvals can be sought via the WA Department of Health online Research Governance Service. Governance approvals can be requested in parallel to requests for HREC approvals.
Most hospitals will have a research governance office or similar. It is strongly recommended that you make contact with a hospital governance officer to discuss the proposed study, prior to making a request for governance approval. The governance officer will be able to explain the process, including the key stakeholders (business managers et al) at the site from whom you may need to receive approvals. You may also need to meet with some of those key stakeholders, in order to discuss the project requirements and to find out if what you are requesting can be easily approved (especially your budget for on-site costs). While this will take up some of your time, it might help to ensure you obtain governance approvals without significant delays.
Please be aware that for commercially sponsored trials the hospital may charge fees for scientific, ethical and governance reviews.
As occurs with changes to HREC approved protocols, changes to recruitment, personnel, funding, etc will likely need to be subject to an amendment process. Advice should be sought from the relevant hospital governance office/officer.
Set up agreements with organisations involved in the trial
The granting agency, or the company if it’s a commercial trial or similar, will likely provide a grant funding agreement. That should be referred to Research Grants and Contracts, who will arrange review, including review by Risk and Legal if necessary, and who will arrange execution by an authorised signatory on behalf of the University.
In many instances, there will also a requirement to enter into agreements with the trial sites – i.e. with one or more public and other hospitals. These agreements are generally referred to as Clinical Trial Research Agreements, and usually use a Medicines Australia template. The Research Grants and Contracts Office can assist with the preparation of these agreements. To enable this to occur, you will need to provide the Research Grants and Contracts Office with a copy of the Clinical Trial Insurance Notification form, along with the standard grant internal forms.
For NHMRC grants we have template agreements that we use to enter into agreements with other research institutions that are participating in the project, such as other universities, and with trial sites. On award of the NHMRC grant, the Research Grants and Contracts Office will work with the lead Chief Investigator on putting in place such agreements. Under these arrangements, UWA would provide funds to the other research institutions, to cover their costs, via a multi-institutional (or shared grant) agreement, using a Go8 template. As well, UWA would provide funds to the trial sites, to cover patient and other costs, under Clinical Trial Research Agreements.
For all clinical trial agreements the Research Grants and Contracts Office will work closely with Risk and Legal, especially on receipt of non-standard agreements and agreements for commercial trials. Additionally, new agreements can be drafted, as may be necessary.
Recovery of costs incurred at WA Department of Health hospital trial sites
For clinical trials, and for other grants that are administered by UWA, where research is being undertaken at a WADoH hospital or other trial site, the hospital should invoice UWA, to recover the cost of services provided by the hospital. Invoices should be forwarded to your Faculty Service Delivery Centre finance team, so that they can arrange payment from the grant funds. As part of the process of obtaining hospital governance approval you may need to provide a budget to the hospital, outlining costs to be incurred at the hospital. You will also be required to provide evidence of the award of the grant. When seeking governance approvals, it may be appropriate to discuss the recovery of costs with the hospital governance staff and with the business managers or equivalent.
Training in Good Clinical Practice
UWA recommends all personnel involved with clinical trials undertake training in Good Clinical Practice (GCP), which is a set of guidelines expected of sponsors, researchers, sites, ethics committees, and project personnel. You may find that hospital HREC approvals and/or governance approvals require evidence of GCP training.
The WA Health Translation Network (WAHTN) offers online GCP training free to UWA staff and project personnel via the Research Education and Training Program.
The free Global Health Training Centre also provides GCP training.
UWA staff can also undertake the Collaborative Institutional Training Initiative Program in GCP.
Clinical trials information resources
- Australian clinical trial handbook
- TGA's clinical trial pages
- NHMRC clinical trials pages
- Clinical Trial Research Agreements (CTRA, at Medicines Australia)
- TGA Note for Guidance on Good Clinical Practice (GCP)
- WHO – ICTRP Search Portal for registered clinical trials
- WHO – ICTRP Primary registries
- Australian & New Zealand Clinical Trial Registry (ANZCTR)
- US National Institute of Health clinical trials registry (ClinicalTrails.gov)
UWA support for Clinical Trials
For HREC and TGA advice:
Dr Mark Dixon
Associate Director Research Ethics and Integrity
Phone: 6488 7613
Email: [email protected]
For research grants and agreements:
Manager Research Grants
Phone: 6488 2033
Email: [email protected]
Risk & Legal Office: to be contacted through the Office of Research Enterprise.
UWA’s Insurance Broker: [email protected].
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