ISRCTN registry

Registry Profile

General Information

Address:
ISRCTN registry
c/o BMC
The Campus
4 Crinan Street
London N1 9XW
United Kingdom

Registry URL:  https://isrctn.com
Registration URL:  https://isrctn.com

Email: info@isrctn.com

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. A record would only be removed from the ISRCTN registry once it is registered if it is fraudulent or is a duplicate of a record already registered on the ISRCTN registry.

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.
Ongoing training, quality assurance checks and regular discussions on 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?
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?
At the application stage, it is compulsory for trial applicants to provide all 24 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.

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.

Editors search the registry for identifiers of submitted records. 

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?
National (Department of Health and Social Care in England) + international remit

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.
Department of Health and Social Care and the Health Research Authority in England, Medical Research Council in the United Kingdom 

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.
https://www.isrctn.com/page/governance26

26. Is the Registry managed by a not-for-profit agency? (ICMJE)
Yes, the ISRCTN registry is owned by a non-profit agency (the ISRCTN company) and administered by BMC, which is part of Springer Nature and is a for-profit company 

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, 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 24 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?

Yes

29. Other Governance information:

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

The registry is funded by trial registration fees and by payment for additional services from the Department of Health and Social Care in England

29.2. What is the name of the agency that manages the registry?
ISRCTN registry
c/o BMC
The Campus
4 Crinan Street
London N1 9XW
United Kingdom

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?
No

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?
https://www.isrctn.com/page/governance

Adhesion to WHO Trial Registration Data Set