March 2019: Japan Regulatory Update

UMIN-CTR now supports TRDS 24

March 11, 2019: UMIN Clinical Trial Repository(UMIN-CTR) shares registered trial data with WHO International Clinical Trials Registry Platform(ICTRP). ICTRP has 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 started supporting the new data set from March 11, 2019. To meet 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.

Changes to trial title: “Scientific title” is separated from the public title: There are four fields for title of the trial, viz., “Public Title”, “Public Title (Acronym)”, “Scientific Title”, and “Scientific Title (Acronym)”, instead of previous “Official Scientific Title” and “Brief Title”.

Changes to IRB contact information: now disclosed to the public: In “Administrative Information” page, registrants should describe contact information of IRBs. This field was not to be disclosed to the public. But the new dataset requests this contact information to be disclosed. Thus, a new field has been added to describe IRB contact information which will be disclosed to the public.

Changes to trial results:

  • 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.
  • Thus, “Last follow-up date” in “Progress” page has been 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 the follow-up period ends.
    1. Number of participants that the trial has enrolled
    2. Date of the first journal publication of results
    3. Baseline Characteristics
    4. Participant flow
    5. Adverse events
    6. Outcome measures
    7. Plan to share Individual Patient Data (IPD)
    8. IPD sharing plan description
  • “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 the registrant.
  • If the 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 the follow-up period ends.

There are some other changes in the field definitions to conform with the ICTRP dataset. The original article is available here.

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