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
The Australian New Zealand Clinical Trials Registry (ANZCTR) is the primary public registry for clinical trials conducted in Australia and New Zealand. It has been housed and managed by the NHMRC Clinical Trials Centre at the University of Sydney since 2005, and in 2007 became one of the first three registries recognized by the World Health Organization as a Primary Registry within its International Clinical Trials Registry Platform (WHO ICTRP) — alongside ClinicalTrials.gov and ISRCTN. Every trial registered with ANZCTR receives an ACTRN (Australian Clinical Trial Registration Number), the bi-national equivalent of a ClinicalTrials.gov NCT number.
Who Needs to Register with ANZCTR
Registration of a clinical trial is not, by itself, a standalone Australian or New Zealand statute in the way FDAAA 801 creates a US legal mandate for ClinicalTrials.gov. Instead, several separate requirements converge on the same practical outcome — prospective registration, almost always with ANZCTR specifically or another WHO-recognized Primary Registry:
- Research ethics requirement: the National Statement on Ethical Conduct in Human Research — the joint NHMRC/Australian Research Council/Universities Australia framework governing human-research ethics review — requires that research assigning participants to health-related interventions be registered in a publicly accessible registry meeting WHO standards before the first participant is recruited. Human Research Ethics Committees (HRECs) apply this requirement when approving a protocol.
- Funding requirement: NHMRC, as a funder, expects registration of the clinical trials it supports, consistent with the National Statement’s registration clause and NHMRC’s own research-integrity expectations.
- Reimbursement requirement: Medicare Benefits Schedule (MBS) items that allow reimbursement of certain trial-related clinical services generally require the trial to be registered in ANZCTR or another WHO-recognized Primary Registry as a condition of eligibility.
- Editorial requirement: journals following ICMJE’s registration policy accept ANZCTR as a qualifying registry, so an Australian- or New Zealand-run trial registering with ANZCTR (rather than ClinicalTrials.gov) still satisfies ICMJE’s publication condition. See CASRAI’s Clinical Trial Registration and Reporting Compliance guide for how ICMJE’s policy works across registries generally.
Relationship to the TGA and Other Australian Bodies
ANZCTR registration is distinct from and does not substitute for the regulatory approvals a trial may separately need. The Therapeutic Goods Administration (TGA) governs whether an unapproved therapeutic good may lawfully be supplied for use in a trial (via the Clinical Trial Notification or Clinical Trial Approval schemes) — a product-safety and lawful-supply function, not a registry. HRECs review and approve the ethics of the protocol itself. AHPRA registers the individual health practitioners who may conduct trial-related clinical care. ANZCTR sits alongside these as the public disclosure layer: a searchable, time-stamped record of what a trial set out to do, independent of whether the underlying product or protocol has cleared TGA or HREC review.
How It Differs From ClinicalTrials.gov
ANZCTR and ClinicalTrials.gov are both WHO ICTRP Primary Registries, but they are scoped to different jurisdictions and neither is a substitute for the other by default. ClinicalTrials.gov’s mandatory-registration mechanism (FDAAA 801) applies to a specific US legal category of trial; ANZCTR’s registration drivers are the National Statement, NHMRC funding conditions, and MBS reimbursement rules described above. A trial with sites in both the US and Australia may need to register in both, since each registry’s own national requirements attach to the trial’s local sites, though a single registration in any WHO-recognized Primary Registry satisfies ICMJE’s editorial policy for publication purposes. The Research Registries guide covers the fuller landscape of WHO ICTRP Primary Registries, including ANZCTR, ISRCTN, the EU’s CTIS, CTRI, ChiCTR, DRKS, and JPRN.
Related Terms
Clinical Trial Registration, Prospective Clinical Trial Registration, ClinicalTrials.gov, Australian Code for the Responsible Conduct of Research.
Machine-readable encodings
Use in your systems
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