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

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

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. The details of how to ensure your trial is notified appear at the Clinical Trials page at UWA Risk and Legal (click here). The chief investigator should ensure that this is done.

Training in Good Clinical Practice

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

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

The free Global Health Training Centre also provides GCP training.

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

UWA support for Clinical Trials

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

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

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