Drug Evaluation Committee
List of registered items for transfer studies from JapicCTI First edition
jRCT-JapicCTI Comparative Table of Registration Items, 2nd ed.
Clinical Evaluation Subcommittee
October 2023
The notification regarding the registration of clinical trial status with the Japan Registry of Clinical Trials was revised (No. 0831/9 issued by the Pharmaceutical Affairs Agency on August 31, 2020) to ensure further transparency and revitalization of clinical trials, and the Japan Registry of Clinical Trials (jRCT) was established as the registration center for clinical trial information. In response to this change, the jRCT has been established to ensure the smooth operation of clinical trials in each company. In response to this, we created the "jRCT-JapicCTI Registration Item Comparison Chart" for the purpose of facilitating the smooth start of use of jRCT by each company, and published it on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ) in September 2020.
In response to the transfer of data from the Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) to jRCT in March 2023, a new "List of Required Registration Items for Studies Transferred to JapicCTI" was created to clarify the required registration items on jRCT for studies transferred from JapicCTI. The list is available for download from the JapicCTI website.
In addition, we have updated the "jRCT-JapicCTI Registration Items Comparison Table" released in September 2020 to reflect the latest status and created a revised second version.
The documents are available in Excel, so you can use the filter function to extract items that are newly required to be registered after the transition to jRCT, and you can examine the information you want to know by yourself.
We hope that the use of these materials will promote the unification and facilitation of clinical trial information registration and help improve patients' access to clinical trial information.
jRCT: Japan Registry of Clinical Trials
Drug Evaluation Committee Deliverables Return to list of all communications