What is the ANZCTR?
The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. The ANZCTR includes trials from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies.
In 2007 the ANZCTR was one of the first three trial registries to be recognised by the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP) as a Primary Registry. WHO recognises registries as Primary Registries if they fulfil certain criteria with respect to data content, quality and validity, accessibility, unique identification, technical capacity and administration. The ANZCTR contributes data to the WHO ICTRP, which was developed in 2007. Trials from all ICTRP Primary Registries can be searched at: www.who.int/trialsearch
What studies should be registered?
Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes (WHO / ICMJE 2008 definition) should be registered, including early phase uncontrolled trials (phase I) in patients or healthy volunteers ( WHO Recommendation / ICMJE policy). If in doubt, registration is recommended.
Read more in the FAQ.
When should studies be registered?
Studies should be registered prospectively, i.e. before the first patient is recruited.
As of the 1st July 2005, the International Committee of Medical Journal Editors (ICMJE, including editors of the Medical Journal of Australia, Lancet, New England Journal of Medicine and others) only consider clinical trials for publication if they are included on a recognised register at the trial's inception. Moreover, the revised Declaration of Helsinki, released in October 2008, states that "Every clinical trial must be registered in a publicly accessible data base before recruitment of the first subject" (paragraph 19).
* In order to fulfil this prospective registration requirement, we recommend that you commence the registration process at least 10 days prior to the anticipated recruitment start date.*
How do I register a trial?
Go to the
Register Trial
section of this website and enter the required data. Remember to save and verify your information before submitting your trial for registration. There are information buttons next to each data entry box to help you enter the correct information. If you wish to download and print the registration application form prior to registering your trial online, please click here [Word] [PDF]. Explanation of the data fields can be also be downloaded. If you have further enquiries about the ANZCTR, please feel free to contact us.
Key points about the ANZCTR
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Publicly owned, managed by a not-for-profit organisation
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All details of trials registered on the ANZCTR are made publicly available
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Registration is voluntary, but if a registrant chooses to register a trial, certain fields are mandatory
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Registration is free of charge
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Responsibility for registration lies with the Sponsor
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The Sponsor is defined by the NHMRC and Therapeutic Goods Administration (TGA) as "an individual, company or institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial"
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It is the Sponsor's responsibility to ensure that the information submitted is
accurate and up-to-date.
Read more in the FAQ.
What information will be recorded?
The registry records a trial's
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objectives
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main design features
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sample size and recruitment status
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treatments under investigation
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outcomes being assessed
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principal investigator
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contact person
The ANZCTR mandatory data items comply with the minimum dataset requirements of
the International
Committee of Medical Journal Editors (ICMJE) and the World Health Organisation (WHO).
Once the submitted data is checked, the trial is allocated a unique registration number.
See our Latest News section for further information.
Read more in the FAQ.