Japan

Japan

Japan Registry of Clinical Trials (jRCT)

Verified on September 9, 2021

Japan has a clinical trials registry, Japan Registry of Clinical Trials (jRCT). It is a World Health Organization (WHO) recognized primary registry. Japan had a network of 3 additional primary registries which included Japan Pharmaceutical Information Center – Clinical Trials Information (JapicCTI), University Hospital Medical Information Network (UMIN-CTR), and Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR). As per the notification published on JMACCT, the clinical trial information registration center has been unified and from September 01, 2020, the information is to be submitted to jRCT. It is mandatory to register the protocol and post results in jRCT, except for bioequivalence studies.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
jRCT Mandatory National Database (includes Ethics Requirement) Sponsor Clinical Trial Application

Interventional

Phase 1 (except bioequivalence studies); Phase 2 to 4

Observational

Japanese
English
JMACCT Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

Phase 1 (except bioequivalence studies); Phase 2 to 4

Observational

Japanese
English
UMIN-CTR Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

Phase 1 (except bioequivalence studies); Phase 2 to 4

Observational

Japanese
English
JapicCTI Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

Phase 1 (except bioequivalence studies); Phase 2 to 4

Observational

Japanese
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
jRCT Registration

Yes

Before the study start date
Results

Yes

Within 1 year of study completion
UMIN-CTR Registration

Yes

Before the study start date
Results

No

Not applicable (NA)
JMACCT Registration

Yes

Before the study start date
Results

Yes

Within 1 year of study completion
JapicCTI Registration

Yes

Before the study start date
Results

Yes

Within 1 year of study completion

Registry Updates


  • June 2021: Japan Registry Update - Updated Field of jRCT A pre-registration content check sheet was posted on June 29, 2021 on Japan Registry of Clinical Trials (jRCT). For registration items of “Other Clinical Studies” and “Clinical Trials”, an input check at the time of registration is added. If the items in the check sheet are not met, the registration can … Continue reading "June 2021: Japan Registry Update"
  • February 2021: Japan Regulatory Update - Japan Clinical Trial Registration System Unification to jRCT Official notification was published on Center for Clinical Trials, Japan Medical Association (JMACCT) regarding unification of Japanese clinical trial registries into jRCT, in February 2021. As per the new notification i.e.  August 31, 2nd year of Reiwa (i.e. 2020), Pharmaceuticals and Herbal Medicines 0831 No. 9, the … Continue reading "February 2021: Japan Regulatory Update"
  • 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 … Continue reading "February 2021: Japan Regulatory Update"

References


  1. Frequently Asked Questions. Japan Registry of Clinical Trials. https://jrct.niph.go.jp/faq Published August 09, 2019. Accessed August 09, 2019.