Clinical Research Information Service (CRiS) of Republic of Korea
임상연구정보서비스
Registry Profile
General Information
Address:
363-951, 187 Osongsaengmyeong2(i)-ro
Osong-eup, Cheongwon-gun
Chungcheongbuk-do
Republic of Korea
Registry URL: https://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp
Registration URL: http://cris.nih.go.kr/cris/inc/login.jsp
Email: criskorea@korea.kr
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?
Republic of Korea
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?
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?
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?
Under development
6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
Under development
6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
Under development
6.4. Please briefly describe these compliance mechanisms.
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.
Korean and English
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?
We have three administrators to check up the all items in the WHO Trial Registration Data Set. If there are items to be completed or modified, administrators will notice for registrant that the items have to be completed or modified on the web and have them re-submitted. After our staff check up the items again, if the items are satisfied with all criteria, we will assign the CRiS number to the registrant. If we need more strict judgement of registered trial’s items, we’ll call a meeting with members that consists of advisory committee or experts on clinical trials and research.
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.
In our CRiS system, clinical researchers enter information that shows whether a clinical trial is registered on other register systems or not. If the clinical trials are registered on other register system, we’re not going to send the XML file to WHO ICTRP. Also, we’ll give a notice for clinical researchers that a single trial can be registered only once. Moreover, CRiS staff check every trial by searching WHO Search Portal.
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?
Republic of Korea
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 and Welfare
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.
In English: http://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp
In Korean: http://cris.nih.go.kr/cris/use_guide/cris_introduce.jsp
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?
Ministry of Health and Welfare
29.2. What is the name of the agency that manages the registry?
Korea Centers for Disease Control and Prevention
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 advisory committee that consists of experts on clinical trials, statistics and computer science. They’ll check up the items in the registered clinical trials and research and deal with technical problems.
Adhesion to WHO trial registration data set