April 2021: Republic of Korea Regulatory Update

Notice for Partial Correction of Input Items and Changes to Existing Registered Research Data

Clinical Research Information Service (CRIS), the primary registry of Korea published a notice on 20 April 2021. In context of the same:

  • Recently, WHO ICTRP announced that some of the choices in the Study Data Sharing Plan for the International Clinical Research Registration Guidelines have been removed. In accordance with the same, CRIS has deleted the “Undecided” selection in the research data sharing plan and changed the registered research data. In case “tentative” is selected for existing registered studies, it has to be changed to “No”.
  • For previously registered studies, where “Undecided” was selected, the data will be changed to “No” collectively. Research that corresponds to data bulk changes will be sent to the registrar’s email. Sponsors can change it to “Yes” if their IPD sharing plan changes.
  • Modifications to input items and changes to existing registered research data are expected further.
  • Detailed information can be accessed through Announcements (nih.go.kr)