Australian New Zealand Clinical Trials Registry (ANZCTR)
- Registry URL: http://www.anzctr.org.au
- Registration URL: https://www.anzctr.org.au/login.aspx?ReturnUrl=%2fregistry%2ftrial_new.aspx
- Funding Agency: National Health and Medical Research Council of Australia; New Zealand Health Research Council
- Managing Agency: NHMRC Clinical Trials Centre, University of Sydney
The ANZCTR is advised by an external Advisory Policy Committee whose role is to advise on the scope, operation, accessibility, sustainability and international obligations of the ANZCTR. The ANZCTR also has an Operational Executive with representatives from the ANZCTR management and the NHMRC Enabling Grant investigators whose role is to oversee the operational aspects of the Registry.
- Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- Does the Registry have documented Standard Operating Procedures (SOPs)?
- Are mechanisms in place to ensure compliance with these SOPs? (eg staff training)
- Description of the compliance mechanisms:
Staff undergo initial training in the submission and query processes. Regular audits are conducted to assess data completeness, data accuracy and data processing timeliness. SOPs are reviewed at monthly staff meetings (or more frequently if required) and assessed annually by the ANZCTR Manager. Staff are given time to attend staff development activities such as journal club and internal / external training courses that will increase their understanding of trial registration principles and procedures.
- Does the Registry agree to participate in the development of Guidelines for Clinical Trial Registries?
- Can the Registry collect and publicly display the WHO Trial Registration Data Set (TRDS)?
Yes, Click here to view the details.
- Languages in which the registered information is displayed:
- What quality control measures does your Registry have in place to make sure that all 20 items in the WHO TRDS are as complete and accurate as possible?
Once a trial is submitted for registration, the ANZCTR staff assess it within 2 working days for completeness (i.e. all mandatory fields are completed), meaningful data and general accuracy and logic. There are additional automated logic checks on certain key fields. If any queries are identified, the ANZCTR staff email these to the registrant and include suggested changes. The Registrant must make these changes on-line and then ‘re-submit’ the trial. The ANZCTR staff again check the re-submitted data and only once all criteria are satisfactorily completed is the trial registered, assigned an ANZCTR (ACTRN) number and made available for public view.
- Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration?
Not applicable: trials are not accepted for registration if they do not provide the complete WHO TRDS
- Does the Registry agree to submit the WHO Trial Registration Data Set, in English, to the Central Repository?
- Does the Registry agree to keep registered information up-to-date?
- Does the Registry agree to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked?
- Does the Registry agree to never to remove a trial once it has been registered?
- Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- The web address where this information is displayed:
http://www.anzctr.org.au and http://www.anzctr.org.au/docs/ANZCTR%20Access%20policy%20-%20V3%2023Apr08.pdf
- Does the Registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a Collaborating Registry in the Registry Network?
- Is the Registry searchable over the Internet at no charge?
- Is the Registry open to all prospective registrants?
- From which countries will the Registry accept trials for registration?