Investigator Initiated Clinical Trials

If you have an idea for a clinical trial but aren’t sure what to do next, this part of the Roadmap might help.

Clinical trials are the critical step translating medical research into healthcare. Because clinical trials recruit people as participants, there are multiple ethical, regulatory, financial, clinical and administrative factors to be considered when setting up your own clinical trial.

The roadmap outlines key steps to help transform your idea into a successful clinical trial. The Roadmap includes practical support and guidance on design, development, resourcing, ethics and governance required for your clinical trial in a complex research environment. 

It is also valuable to consider how your clinical trial offers value to patients, the healthcare system and our community as well as ensuring the trial adheres to regulatory policies and good governance practices.

It is important that researchers who undertake human health research and clinical trials in Australia ensure that their research is safe, respectful, responsible, high quality and beneficial for Aboriginal Australians.  Specific information regarding this is included in the following sections: ‘Test your Idea’ and ‘Who Needs to Know.

Before you begin you will require Good Clinical Practice (GCP) certification. GCP certification is an internationally accepted standard for people working on the design, conduct, recording and reporting of clinical trials. It ensures staff conducting clinical trials are working to international best practice. Information about GCP certification can be found here and GCP Providers are listed here.

The Roadmap also highlights key groups, organisations and services who are available to advise and assist you during the development of your clinical trial. There are also key local governance teams that you must contact; seek their input early. The groups, offices and services will vary depending where your will be conducted, for example:

  • Your local health district
  • Your hospital or health service, your department, your practice group
  • Your local community, your patients, your local advocacy and consumer groups, your broader community network
  • Your university, your department, school or discipline
  • The Hunter Medical Research Institute and other research support centres


Getting in touch at the right time and consulting with the appropriate offices and services will help you to establish your trial successfully and quickly.


Is Your Study a Clinical Trial


Test Your Idea