Author: Shruti Kulkarni

March 2023: Japan registry update

On March 06, 2023, a notice was released on the Japan Registry of Clinical Trials (jRCT) regarding the completion of data migration. As per the notice, users can now view and update the registered information of JapicCTI and Japan Medical Association Clinical Trial Registration System (JMACCT-CTR) on the jRCT system.

  • The jRCT system now allows users to view the data of JapicCTI and JMACCT-CTR, as well as register new trials as usual.
  • For guidance on login methods and migrating data for the first time, users can refer to the ‘Operation Manual’ and ‘Frequently Asked Questions’.
  • A list of study IDs before and after migration has been posted for reference.

Please click here to go to the original update.

March 2023: Japan registry update

On March 02, 2023, the Japan Registry of Clinical Trials (jRCT) published a notice regarding the updated schedule for data migration. The registered data from two registries – the Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and the Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) – will be migrated to the Clinical Research Submission and Disclosure System of jRCT.

  • The data migration will follow the schedule below:

– jRCT suspension period: March 02 to March 06, 2023

– JMACCT-CTR and JapicCTI data will be updated and viewable on jRCT after migration: March 06, 2023

  • The direct link URLs for JMACCT-CTR and JapicCTI will become invalid, and it is suggested to change them to the URLs for jRCT after migration.
  • The detailed transition rules will be posted on the jRCT page after the transition.
  • In terms of user ID, if the same email address is used in multiple databases, the order of priority will be jRCT > JMACCT-CTR > JapicCTI. After migration, lower priority IDs cannot be used.
  • JMACCT-CTR or JapicCTI login IDs can be used to log in to the jRCT registry, but a new password needs to be issued the first time. Detailed steps are outlined in the accompanying document.

Please click here to go to the original update.

February 2023: Japan registry update

On February 16,2023, a notice regarding postponement of data migration was published on Japan Registry of Clinical Trials (jRCT). The listed updates are as follows:

  • The initial schedule of the data migration is postponed due to the time required for the data migration associated with the integration of clinical trial and clinical research databases.
  • jRCT will not be suspended after February 16, 2023 (the initially announced suspension period for registration and browsing of trials).
  • The revised date of data migration and suspension period of registration and browsing will be announced as soon as it is decided.

Please click here to go to the original update.

January 2023: Ireland regulatory update

Deadlines for the transition to the Clinical Trials Regulation (CTR) were recently discussed in a post by the Health Products Regulatory Authority (HPRA), Ireland.

The details are summarized below:

  • Only until January 25, 2023, will HPRA and the National Office for Research Ethics Committees (NREC; [email protected]) accept new or initial applications under the Clinical Trials Directive (CTD).
  • The HPRA and NREC must receive the new clinical trial application at the same time in order to validate and authorize it. The NREC website lists the deadlines for January.
  • If the simultaneous application to NREC cannot be filed at the time, it is advisable to submit a new clinical trial application in compliance with the updated Clinical Trial Regulation (CTR).
  • Until 30 January 2025, significant changes to trials authorized under the CTD are allowed.
  • By January 30th, 2025, all trials authorized under CTD must be completed or transferred to CTR.

Further details can be found here

January 2023: Update on Italy’s Register of Observational Studies

On December 22, 2022, a press release about the Register of Observational Studies (RSO) was posted on the website of the Italian Medicines Agency (AIFA).

On January 31st, the Register of Observational Studies (RSO) will go live.

In the press release, the following operational procedures and RSO usage were described in detail:

Access to the RSO

To access the RSO website, the sponsors need to connect to the AIFA Online Services Portal available at the web address: https://servizionline.aifa.gov.it/.

Promoters and CRO area

  • Registration on RSO is mandatory only for new requests (paper application/notification), whose letter of transmission was submitted to the Ethics Committee (EC) after 1 January 2023.
  • For studies submitted to the EC after the publication of this press release, inclusion in the RSO must be carried out at the same time as the paper submission to the EC.
  • The initiation data (in the first center) and completion of the study in Italy must be submitted within 30 days of the opening/conclusion of the study
  • A summary of the study results should be submitted within twelve months of the conclusion of the study.

Ethics committee area

  • The ECs are required to enter the data within their competence in the RSO within 30 days of the decision or receipt of the paper application

External users’ area

  • The new RSO system will allow external users, after registering with AIFA online services, to search and consult observational studies of their own competence and/or interest (e.g., Regions, citizens/patients).

Support tools and services

AIFA has provided email addresses for regulatory ([email protected]) and technical support ([email protected]).

The press release also provides links to the following guidance manuals for more details

Manual – Ethics Committee Profile

Manual – External User Profile

Manual – Applicant User Profile

Further details can be found here.

January 2023: Japan Registry Update

On December 27, 2022, a notice announcing the migration of registered data from the registries, Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) to the Clinical Research Submission and Disclosure System of jRCT was published on Japan Registry of Clinical Trials (jRCT). The listed updates are as follows:

  • The transition date, February 20, 2023, will see a one-day suspension of jRCT. As expected, the revised and relocated data will be accessible in jRCT on February 21, 2023.
  • Study data cannot be updated on JMACCT-CTR and JapicCTI during the migration; however, data can be updated on jRCT once the migration is complete.
  • Changes and new registrations on jRCT are not permitted during the migration, and the changes and registrations must be finished by Thursday, February 16, 2023.
  • The transitional trials will receive a new jRCT number, but jRCT users can still search for them using their individual JMACCT-CTR and JapicCTI trial IDs.
  • The data fields for the transitional trials would adhere to the JMACCT-CTR and JapicCTI guidelines. If any of the WHO24 items are missing for a transitional trial, they can be added and updated on jRCT.
  • JMACCT-CTR and JapicCTI won’t be available after January 31, 2023, and February 21, 2023, respectively.

Please click here to go to the original update.