Australian New Zealand Clinical Trials Registry (ANZCTR)

Registry Profile

General Information

Address:
NHMRC Clinical Trials Centre
Locked Bag 77, Camperdown NSW 2050
Australia

Registry URL: https://www.anzctr.org.au
Registration URL:  https://www.anzctr.org.au

Email:  info@anzctr.org.au

Content

1. Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
Yes

2. Is the Registry open to all prospective registrants (ICMJE), either internationally, or within one or more specific countries?
Yes

2.1. From which countries will the Registry accept trials for registration?
All countries

2.2. If the Registry is not open to ALL registrants (that is, accepts trials only from a particular sponsor, health care condition (eg cancer), intervention, etc) please specify which trials the Registry is open to.
Not applicable

3. Is the Registry able to collect and publicly display the WHO Trial Registration Data Set? (ICMJE)
Yes

4. Does the Registry endeavour to keep registered information up-to-date?
Yes

4.1. Does the Registry have a reminder system to facilitate the submission of updated information by the responsible registrant?
Yes

4.2. Does the Registry highlight or flag records that are not current (have not been updated in more than 12 months) so readers are aware that information contained in such records may not be current?
Yes

5. Does the Registry never remove a trial once it has been registered?
Yes

Quality and Validity

6. Does the Registry have a mechanism in place to ensure the validity of the registered data? (ICMJE)
Yes

6.1. Does the registry contact Responsible Registrants when one or more items in the Trial Registration Data Set are incomplete or potentially inaccurate?
Yes

6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
Yes

6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
Yes

6.4. Please briefly describe these compliance mechanisms.
New staff are trained during a two month orientation period. At weekly team meetings compliance issues are addressed as they arise. Annual data audits and duplication checks every 250 registered trials are used to assess data quality and validity. Monthly statistics are reviewed to assess time to registration and other metrics of performance.

7. Does the registry maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked?
Yes

8. It is desirable that Primary Registries participate in the development of the International Standards for Clinical Trial Registries. Does the Registry agree to participate in the development of these standards?
Yes

Accessibility

9. Is the WHO Trial Registration Data Set accessible to the public at no charge? (ICMJE)
Yes

10. Is the WHO Trial Registration Data Set electronically searchable? (ICMJE)
Yes

11. Is the WHO Trial Registration Data Set available in English?
Yes

12. Can registrants submit a trial for registration at any time of day on any day of the week (24 hours a day, seven days a week)?
Yes

13. Can the register be searched at any time of day on any day of the week (24 hours a day, seven days a week)?
Yes

14. It is desirable that the WHO Trial Registration Data Set be available in the language/s of the countries served by the registry. Please indicate the languages in which the registered information is displayed.
English

14.1. If trials are registered in more than one language, does the registry check the quality of translation?
Not applicable

15. What quality control measures does the registry have in place to make sure that all items in the WHO Trial Registration Data Set are as complete and accurate as possible?

After submission of a trial registration request, the ANZCTR staff assess the accuracy and validity of the data submitted by checking the information supplied against the standards required for the 24 items TRDS. If information appears missing, inconsistent or obviously inaccurate, the data are queried with the Registrant via email. Registrants are required to make the required changes themselves online and re-submit the trial. Once the trial submission fulfils the 24 item TRDS requirements, the trial is registered by the ANZCTR staff, after which a registration number and date are automatically generated and the trial is publicly displayed on the ANZCTR website.

Unambiguous Identification

16. Does the Registry have processes in place to prevent the registration of a single trial more than once on their register?
Yes

16.1. Please briefly describe these processes.

Once a trial is submitted, the ANZCTR staff search the ANZCTR registry and the WHO ICTRP for trials with similar information regarding intervention, conditions and/or acronyms. If any trials are found that appear to be the same trial as that submitted for registration, the staff query the Registrant to confirm that the newly submitted trial is not a duplicate.

17. Does the Registry agree to facilitate the retrospective linking (or bridging) on the WHO Search Portal of a single trial registered with more than one registry by encouraging Responsible Registrants to enter secondary identifiers, including the UTN?
Yes

18. Does the Registry agree, as part of the registration process, to search the WHO Search Portal to ascertain if the trial has already been registered on another WHO Primary Registry?
Yes

Technical Capacity

19. Does the Registry agree to submit the WHO Trial Registration Data Set for all records on their registry to the Central Repository?
Yes

19.1. Is the registry regularly submitting data to the ICTRP?
Yes

20. Does the Registry have access to a database that is used to store and manage the submitted data?
Yes

20.1. If not, please provide details of the database that will be used and where it is based.
Not applicable

21. Does the Registry have access to adequate information technology support?
Yes

22. Does the Registry have adequate security and other provisions against data corruption/loss?
Yes

Administration and Governance

23. Does the Registry have at least a national remit?
Yes

23.1. From which countries does the Registry have the remit to act as their Primary Registry?
Australia and New Zealand

24. Does the Registry have a letter of support from the relevant Ministry of Health or other agency?
Yes

24.1. Please specify the names of the government agencies that have given their support.

Commonwealth Department of Health

25. Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
Yes

25.1. Please indicate the web address where this information is displayed.
On the ANZCTR home page (www.anzctr.org.au) under the ‘About us’ section.

26. Is the Registry managed by a not-for-profit agency? (ICMJE)
Yes

27. Should the register cease to function, does the register agree that at least the WHO Trial Registration Data Set for all trial records will be transferred to a WHO Primary Register?
Yes

27.1. Does the registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a WHO Primary Registry?
Yes

28. It is desirable that Primary Registries have a strategy in place addressing the medium to long term sustainability of the registry. Does the Registry have such a strategy in place?
Yes

29. Other Governance information:

29.1. What is the name of the agency (or agencies) that fund the registry?

Commonwealth Department of Health (Australia)

Commonwealth Department of Education via the National Collaborative Research Infrastructure Strategy (NCRIS), administered by Therapeutic Innovation Australia (TIA)

Health Research Council of New Zealand

29.2. What is the name of the agency that manages the registry?
NHMRC Clinical Trials Centre, University of Sydney

29.3. Is the agency that manages the registry a for-profit agency?
No

29.4. If the agency is for-profit, is the data on the register (database) also available on a Registry that is managed by a not-for-profit agency?
Not applicable

29.5. If the answer to 29.4 is "yes", then please specify the name of the additional Registry.
Not applicable

29.6. Please describe any other ownership or governance issues of relevance to the register. (eg Does the register have an Advisory Board. If so, what is its role?
The ANZCTR has an external Advisory Committee comprised of key stakeholders which meets annually and advises on scientific and strategic issues. It also has a management group which advises on operational and scientific aspects of the Registry.

Adhesion to WHO Trial Registration Data Set