Investigator Initiated Studies
This section of the website is currently in development and will be progressively added to.
Please contact the Research Office if you would like specific information added to assist you or your research team.
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Training
Members of research teams must be qualified and skills to conduct the roles and procedures they are responsible for in the research project. PIs must have completed Good Clinical Practice Training. Please refer to the Education and Training for...
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Presubmission review
The HREC Chair is happy to meet with researchers prior to submitting the application. The following information should be prepared for review: Protocol including the below Literature review Research questions defined including hypotheses Study design...
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Protocols
For investigator initiated studies there are several templates you could use as a starting point: The Spirit Group have developed a Standard Protocol Items: Recommendations for Interventional Trials which can be accessed from the SPIRIT website...
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Therapeutic Goods
The Therapeutic Goods Administration (TGA) protects the health and wellbeing of the community by regulating and monitoring all therapeutic goods that are distributed in Australia. If you are conducting research related to a therapeutic good, the TGA...
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Trial Registration
Clinical Trials must be registered with a World Health Organisation approved Clinical Trial Registry prior to recruitment of the first particpant. Detailed information including links to approved registries is available at Australian Cinical Trials...