Ethics & Governance
Conducting a clinical trial or research study in Australia
Human Research Ethics Committee (HREC) approval including approval of a written participant information sheet & consent form (a master copy).
Site specific assessment authorisation (research governance) from your institution, this may include review of the indemnity arrangements, establishment of a contract with the trial organiser (if applicable) and approval of any site specific documents.
Completion of the Therapeutic Goods Administration (TGA) Notification Scheme (CTN Scheme) or the Clinical Trial Exemption Scheme (CTX Scheme) if your trial involves a new therapeutic good or medical device or a new use of an existing therapeutic good or medical device.
Please note that you require your full protocol, patient information sheet and consent form, your data collection forms and any follow up questionnaires going to out to families. If you are linking with any data registries, this may involve additional approvals.
If you are have a website that is open to the public, then you will need ethics approval for the content.
Please consult with a statistician, your pharmacy, if relevant, medical records data manager and any other expert/personnel who you will require to complete the protocol and implement your study.
To find out more about the main requirements, download the rough guide to ethics governance and regulatory approvals in Australia.
Conducting a clinical trial or research study in New Zealand
The main requirements for commencement of a clinical trial are: