Chinese Clinical Trial Registry (ChiCTR)

中国临床试验注册中心

Registry Profile

General Information

Address:
No. 37
Guo Xue Xiang, Chengdu
China

Registry URL: http://www.chictr.org.cn

Registration URL: http://www.medresman.org/login.aspx

Email: chictr@scu.edu.cn

Partner Registries with which this Primary Registry is affiliated:
Centre for Clinical Trials, Clinical Trials Registry - Chinese University of Hong Kong

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.
1. Training staffs: all staffs have been trained by SOPs;
2. Final checking: two steps to check the registering trials:
(1) Primary checking by staffs; (2) Final checking by administrator.

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.
Both Chinese and English for those trials registered by registrants from China mainland. However, if the Hong Kong Registry’s data will be included as a partner registry of ChiCTR in the future, English will be the sole language for display for the trials registered in Hong Kong Registry. Trials conduct in other counties also be displayed in English only.

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?
(1) Make SOPs
(2) Training staffs
(3) Two checking steps (primary and final checking)

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.
Search in WHO ICTRP search portal when perform the primary checking.

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?
China

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.
Ministry of Health of China

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.
http://www.chictr.org.cn/abouten.aspx

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?
West China Hospital, Sichuan University

29.2. What is the name of the agency that manages the registry?

Chinese Evidence-Based Centre, Chinese Cochrane Centre, West China Hospital, Sichuan University

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?
We have an Advisory Board. The role of Advisory Board include (1) policy consultation; (2) methodology consultation.

Adhesion to WHO Trial Registration Data Set