UMIN Clinical Trial Repository(UMIN-CTR) shares registered trial data with WHO International Clinical Trials Registry Platform(ICTRP). Recently ICTRP revised its standard data set to version 1.3.1(WHO Trial Registration Data Set, Version 1.3.1 , that includes detailed description of trial results. UMIN-CTR will support the new data set since Mar 11 2019. To met the registry criteria, registrants should fill up trial result field when they update their trial records since 12 months after the follow-up period ends.
We also update some field definitions at this update. Details are below.
☐ Currently we request “Official Scientific Title” and “Brief Title” for the title of trial. This does not match with the ICTRP dataset.
☐ We set four title fields to be conformant with ICTRP data set: “Public Title”, “Public Title(Acronym)”, “Scientific Title”, and “Scientific Title(Acronym).
☐ In “Administrative Information” page, registrants should describe contact information of IRBs. This field was not be disclosed to public. But the new dataset requests this contact information to be disclosed.
☐ So we added a new field to describe IRB contact information which will be disclosed to public.
☐As ICTRP requests, all trial registrations should have trials results written after their follow-up period ends.
☐ UMIN-CTR requests registrants to fill up all of results fields when they will update the registration since 12 months after follow-up period ends.
☐ To apply this limit , “Last follow-up date” in “Progress” page was changed to required field.
☐ These new fields are appended on “Result” page. All of these items are required to be filled up since 12 months after follow-up period ends.
☐ “Number of participants that the trial has enrolled” is now required field if “Recruitment status” in “Progress” page is one of “No longer recruiting”, “Main results already published”, “Terminated” or “Completed”.
☐ “URL releasing protocol” , “URL related to results and publications”, and “Results” fields was not mandatory before this revision, however, now these are mandatory since 12 months after follow-up period ends.
☐ If any text is filled in “Results” field, “Results date posted” field will be automatically filled by the system. This field cannot be updated by registrant.
☐ If registrant has any reason not to fill up results field, check “Delay Expected” checkbox on “Result” page, and write the reason in “Results Delay Reason” field. If these fields are written, the system will accept updates without results even 12 months after follow-up period ends.