Examples
Worked examples
- Is an instance
An investigator-initiated Phase 3 trial run across sites in Sydney and Auckland registers with ANZCTR before enrolling its first participant, receiving an ACTRN in the format ACTRN12621000000000, so the trial satisfies both the National Statement's registration requirement and, if the sponsor later seeks Medicare Benefits Schedule reimbursement for trial-related services, the MBS registration condition.
- Is an instance
A manuscript reporting an Australian-run randomized controlled trial cites its ACTRN in the methods section so ICMJE-following journal editors can confirm the trial was registered prospectively, in the same way a US-based trial would cite an NCT number from ClinicalTrials.gov.
Counter-examples
Looks similar, but isn't
- Not an instance
A trial run only at sites in the United States and registered solely on ClinicalTrials.gov is not registered with ANZCTR and does not need to be — the two registries are separate national/regional Primary Registries within the WHO ICTRP network, not competing options for the same trial; a genuinely multi-country trial with Australian or New Zealand sites, however, may register with either (or, less commonly, both).
- Not an instance
TGA approval of a therapeutic good for use in a trial is a separate regulatory step from ANZCTR registration — the TGA governs whether an unapproved drug or device may lawfully be supplied for trial use in Australia, while ANZCTR is a public disclosure registry with no approval authority; a trial can be registered on ANZCTR without yet having, or ever needing, TGA approval, and vice versa.
Editorial commentary
ANZCTR (the Australian New Zealand Clinical Trials Registry) is the primary clinical trial registry for Australia and New Zealand, operated by the NHMRC Clinical Trials Centre at the University of Sydney. It is one of the primary registries in the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) network, alongside registries such as ClinicalTrials.gov and the EU Clinical Trials Register.
Why researchers register with ANZCTR
Registering a trial on ANZCTR (or another WHO-recognized primary registry) before enrolling the first participant satisfies the trial-registration requirement most biomedical journals apply under ICMJE’s recommendations, and is a standard condition of ethics approval and, for many studies, funding, across Australian and New Zealand institutions. ANZCTR entries capture the standard WHO trial registration data set: the trial’s design, intervention, primary and secondary outcomes, recruitment status, and sponsor and contact details, and each registered trial receives a unique ACTRN (Australian Clinical Trial Registration Number).
ANZCTR vs. ClinicalTrials.gov
A trial run in Australia or New Zealand does not need to register with ANZCTR specifically to satisfy ICMJE’s requirement — registering with any WHO-recognized primary registry, including ClinicalTrials.gov, is generally sufficient. Many multinational trials that include Australian or New Zealand sites register in both, since local ethics committees and funders in the region often specifically expect an ANZCTR entry.
References
- ANZCTR (anzctr.org.au)
- WHO International Clinical Trials Registry Platform (ICTRP)
- ICMJE Recommendations, clinical trial registration
Frequently Asked Questions
What is an ACTRN?
An ACTRN (Australian Clinical Trial Registration Number) is the unique identification number ANZCTR assigns to every trial registered in its system, comparable in function to the NCT number that ClinicalTrials.gov assigns. It identifies the trial in publications, ethics submissions, and other regulatory correspondence.
Who operates ANZCTR?
ANZCTR is operated by the NHMRC Clinical Trials Centre at the University of Sydney.
Is ANZCTR recognized by the World Health Organization?
Yes. ANZCTR is one of the primary registries in the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) network, alongside registries such as ClinicalTrials.gov and the EU Clinical Trials Register.
Who is required to register a trial with ANZCTR?
Registering a trial before enrolling its first participant satisfies the trial-registration requirement most biomedical journals apply under ICMJE’s recommendations, and it is a standard condition of ethics approval and, for many studies, funding, across Australian and New Zealand institutions.
If a trial is already registered on ClinicalTrials.gov, does it also need to register with ANZCTR?
Not necessarily to satisfy ICMJE’s requirement — registering with any WHO-recognized primary registry, including ClinicalTrials.gov, is generally sufficient. Many multinational trials with Australian or New Zealand sites register with both, however, since local ethics committees and funders in the region often specifically expect an ANZCTR entry.
What information does an ANZCTR registration include?
An ANZCTR entry captures the standard WHO trial registration data set: the trial’s design, intervention, primary and secondary outcomes, recruitment status, and sponsor and contact details.
Machine-readable encodings
Use in your systems
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