c/o BioMed Central
4 Crinan Street
London N1 9XW
- Registry URL: http://isrctn.com
- Registration URL: http://isrctn.com
- Email: firstname.lastname@example.org
- 1. Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- 2. Is the Registry open to all prospective registrants (ICMJE), either internationally, or within one or more specific countries?
- 2.1. From which countries will the Registry accept trials for registration?
- 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.
- 3. Is the Registry able to collect and publicly display the WHO Trial Registration Data Set? (ICMJE)
- 4. Does the Registry endeavour to keep registered information up-to-date?
- 4.1. Does the Registry have a reminder system to facilitate the submission of updated information by the responsible registrant?
- 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?
- 5. Does the Registry never remove a trial once it has been registered?
Quality and Validity
- 6. Does the Registry have a mechanism in place to ensure the validity of the registered data? (ICMJE)
- 6.1. Does the registry contact Responsible Registrants when one or more items in the Trial Registration Data Set are incomplete or potentially inaccurate?
- 6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
- 6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
- 6.4. Please briefly describe these compliance mechanisms.
Ongoing training, spot checks and regular discussions re how to improve/modify standards.
- 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?
- 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?
- 9. Is the WHO Trial Registration Data Set accessible to the public at no charge? (ICMJE)
- 10. Is the WHO Trial Registration Data Set electronically searchable? (ICMJE)
- 11. Is the WHO Trial Registration Data Set available in English?
- 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)?
- 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)?
- 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.
- 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
- 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?
At the application stage, it is compulsory for trial applicants to provide all 20 data items. ISRCTN verifies that content is provided for all fields and that the content is applicable. If all the information is not provided, the trialist is contacted and the reasons why are recorded.
- 16. Does the Registry have processes in place to prevent the registration of a single trial more than once on their register?
- 16.1. Please briefly describe these processes.
- 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?
- 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?
- 19. Does the Registry agree to submit the WHO Trial Registration Data Set for all records on their registry to the Central Repository?
- 19.1. Is the registry regularly submitting data to the ICTRP?
- 20. Does the Registry have access to a database that is used to store and manage the submitted data?
- 20.1. If not, please provide details of the database that will be used and where it is based.
- 21. Does the Registry have access to adequate information technology support?
- 22. Does the Registry have adequate security and other provisions against data corruption/loss?
Administration and Governance
- 23. Does the Registry have at least a national remit?
- 23.1. From which countries does the Registry have the remit to act as their Primary Registry?
National (Department of Health in England) + international remit
- 24. Does the Registry have a letter of support from the relevant Ministry of Health or other agency?
- 24.1. Please specify the names of the government agencies that have given their support.
Department of Health in England + Medical Research Council + Wellcome Trust
- 25. Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- 25.1. Please indicate the web address where this information is displayed.
- 26. Is the Registry managed by a not-for-profit agency? (ICMJE)
- 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?
- 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, in January 2007, the ISRCTN agreed to join the Register Network on the following basis:
- The ISRCTN data is made available as is.
- The WHO ICTRP Secretariat has been made aware of the possible differences between the 20 items list and the current structure of the ISRCTN Registry.
- The ISRCTN will continue to modify/improve its structure and processes in order to meet its objectives and will let the WHO ICTRP Secretariat know of any major development.
- 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?
- 29. Other Governance information:
- 29.1. What is the name of the agency (or agencies) that fund the registry?
Funded by trial fees
- 29.2. What is the name of the agency that manages the registry?
c/o BioMed Central
Floor 6, 236 Gray's Inn Road
London WC1X 8HL
- 29.3. Is the agency that manages the registry a for-profit agency?
- 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?
- 29.5. If the answer to 29.4 is "yes", then please specify the name of the additional Registry.
- 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?