Japan

Japan

Japan Registry of Clinical Trials (jRCT)

Verified on December 2, 2022

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


  • September 2022: Japan Registry Update - A notice regarding the discontinuation of the Clinical Trial Promotion Center was posted on Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR) on September 08, 2022, and the updates are summarised below: The JMACCT-CTR will be abolished and the eTraining Center for Clinical Trials will be discontinued on January 31, 2023. … Continue reading "September 2022: Japan Registry Update"
  • August 2022: Japan Registry Update - A notice regarding the discontinuation of the Clinical Trial Promotion Center was posted on Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR) on August 23, 2022: On August 23, 2022, at the 6th meeting of the Board of Directors of the Japan Medical Association, it was decided to abolish the Clinical … Continue reading "August 2022: Japan Registry Update"
  • July 2022: Japan Registry Update - A notice regarding ‘Preparation of Change notifications’ is posted on Japan Registry Clinical Trial (jRCT) on July 08, 2022: According to the notice, for Specific and Non-specific clinical research, it is now possible to make minor changes and non-notification changes to the record. Minor changes and non-notification changes to items of the record can be … Continue reading "July 2022: Japan Registry 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.