February 2021: Japan Regulatory Update

Updated Fields of jRCT

Below updates were made to the jRCT system for “Specific clinical research”, “Other clinical research (non-specific clinical research only)”, and “Regenerative medicine research” on February 01, 2021:

  • Added the following 4 items in the initial application, change application, and minor change application (regeneration only): about ‘Plan to share IPD’, ‘Plan to share IPD’, ‘Explanation of plan’, and ‘Plan description’
  • Removed the selection of ‘Undecided’ from “Plan to share IPD data” in the end notification, and only “Yes” or “No” needs to be selected
  • Removed the selection of ‘Undecided’ from “Plan to do” and made only “Yes” and “No” for ‘IPD data sharing’ of Plan to share IPD data of ‘Other clinical research’ and ‘Clinical trial’ in initial application, change application, minor change application (other than clinical trial), completion notification.

Please click here to go to the original update.

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