Research

Clinical Trials

A focus on research of an international quality and the fostering of an outstanding research culture have positioned UWA as one of the best universities in Australia and in the top 150 in the world.

Further information

  • Hospitals
  • NHMRC Clinical trials
  • TGA Clinical trials
  • US Funding

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 initiation, management, and financing of 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 Note for Guidance on Good Clinical Practice.

Local Sponsor – the Local Sponsor is responsible for the conduct of the Study in Australia.

Chief Investigator – the person who has the overall day-to day responsibility for managing the Study.  A Chief Investigator responsible for conduct of a Clinical Trial is also referred to as a Principal Investigator in the agreements.

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.

How to have UWA register a clinical trial notification (CTN) with the TGA

The TGA no longer accepts the paper-form for Clinical Trials Notification (CTN).  Notifications must now be lodged via the TGA's new online system.  UWA has a login for this system and can enter the details for you.  There are more questions in the online system than were on the old form, so we have created a form to collect this information.

Please use the UWA Clinical Trials Notification form, which is available in MS-Word format from here:

If you have a login Id to TGA's system, please feel free to enter your own CTNs, however, please send a copy of the submitted CTN to humanethics@uwa.edu.au so that we can ensure it is listed on the clinical trials insurance policy. 

Signatures?

CTNs no longer require ink signatures.  However, when we lodge a CTN we need to know that the people being named in the form approve of being listed:

  1. Sponsor: If the named sponsor is to be UWA's Deputy Vice Chancellor for Research, we will obtain that approval, otherwise please forward and email from  the person taking responsibility to our office.
  2. 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.
  3. CI: The form you send us implies that the named Chief Investigator is willing to be listed as CI.
  4. Site: Please forward and 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 need: institution, name, role, contact phone, and email address.

UWA clinical trial form
Form to ask UWA to enter CTN details

Set up agreements with organisations involved

You are likely to need legal agreements between the University and some of the following: a hospital, a trial site, and/or partner organisations. UWA Legal Services can assist you with this, but you should start by discussing a Clinical Trials Research Agreement (CTRA) with management at the other organisations.  UWA recommends using the standard templates at Medicines Australia for these agreements.

Hospitals in particular are likely to expect their own ethics review or similar.  Advice on this is available here

You are likely to need legal agreements between the University and some of the following: a hospital, a trial site, and/or partner organisations. UWA Research Grants and Contracts Office can assist you with this, but you should start by discussing a Clinical Trials Research Agreement (CTRA) with management at the other organisation(s). 
UWA recommends using the NHMRC Multi Institutional Agreement for Clinical Trials, or the standard templates at Medicines Australia for these agreements. For a better understanding of UWA’s contractual requirements for clinical trials, the following information is provided:

To assist Research Grants and Contracts Office with the preparation of the Clinical Trial Research Agreement, complete this Notification form and the Acceptance of Offer form and send to the office.

Where applicable, the Research Grants and Contracts Office may engage Risk & Legal for additional support - specific advice regarding these agreements (including drafting of any special conditions) or for the review of  third party agreements.  Risk & Legal requires the completion of this Notification in order to provide advice.

Make sure trial is insured

UWA has an insurance policy to cover clinical trials.  However, trials must be explicitly notified on this policy to be covered. To notify UWA’ insurance and ensure your Trial is covered, please complete the Clinical Trial Notification and send to UWA insurance (uwainsurance@ajg.com). The chief investigator should ensure that this is done as soon as possible after receiving Ethics approval. UWA Insurance will advise you of any additional insurance requirements or additional premiums. 

Training in Good Clinical Practice

UWA recommends all personnel involved with clinical trials take training in Good Clinical Practice which is a set of guidelines expected of sponsors, researchers, sites, ethics committees, and project personnel.

WA Health Translation Network (WAHTN) offers online training in Good Clinical Practice free to UWA staff and project personnel via the Research Education and Training Program (RETP).

The free Global Health Training Centre also provides Good Clinical Practice training.

UWA staff can also take the Collaborative Institutional Training Initiative (CITI Program) in Good Clinical Practice.

UWA support for Clinical Trials

For support with the administration of clinical trials at UWA, contact:

For HREC and TGA advice:

Dr Mark Dixon
M459, Research Enterprise
The University of Western Australia
Perth WA 6009
Phone: +61 8 6488-7613
Email: Mark.Dixon@uwa.edu.au

For research grant applications and agreements:

Rob Roche
M459, Research Enterprise
The University of Western Australia
Perth WA 6009
Phone: +61 8 6488-2033
Email: Robert.Roche@uwa.edu.au

Risk & Legal Office: to be contacted through ORE only.

AJG Insurance Broker: uwainsurance@ajg.com.

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