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 Organization 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.
Key points about the ANZCTR
- Publicly owned, managed by a not-for-profit organisation
- All details of trials registered on the ANZCTR are made publicly available
- Registration is voluntary, but if a registrant chooses to register a trial, certain
fields are mandatory
- Registration is free of charge
- Responsibility for registration lies with the sponsor
- 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"
- It is the sponsor's responsibility to ensure that the information submitted is accurate
What information will be recorded?
The registry records a trial's
- main design features
- sample size and recruitment status
- treatments under investigation
- outcomes being assessed
- principal investigator
- 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 Organization (WHO). Once the submitted
data complies with these requirements, it will be allocated a unique registration number.
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