Resources for Clinical Trials in Australia

Australia’s clinical trials environment is complex, with various responsibilities resting with institutions, private organisations and companies, State or Territory Governments and the Commonwealth Government.

Below are a selection of resources that may be useful when conducting a clinical trial in Australia. 

Legislation, Regulations and Guidelines 

There are a number of Commonwealth legislation, regulations and guidelines to be considered when conducting a clinical trial in Australia. The resources listed below may be helpful in the first instance.

Note: the above list of laws and resources is indicative only.

Trial – start up

The information below may be helpful when planning a clinical trial.

Why conduct a clinical trial in Australia?

Site capability, feasibility and authorisation

Ethical considerations

Forms, fees & other resources

Trial - First participant to finish

The information below may be helpful once the clinical trial has commenced.

Trial registration

Research monitoring

The report

Closing the trial

Publishing results

Submitting a report to a marketing authorisation body

Post completion

State and Territory resources

Each State and Territory has different legislation or guidance material.  Below is an overview of some of the key information that can differ from each State and Territory.