April 2021: Republic of Korea Regulatory Update

Notice for Partial Correction of Input Items and Changes to Existing Registered Research Data

Clinical Research Information Service (CRIS), the primary registry of Korea published a notice on 20 April 2021. In context of the same:

  • Recently, WHO ICTRP announced that some of the choices in the Study Data Sharing Plan for the International Clinical Research Registration Guidelines have been removed. In accordance with the same, CRIS has deleted the “Undecided” selection in the research data sharing plan and changed the registered research data. In case “tentative” is selected for existing registered studies, it has to be changed to “No”.
  • For previously registered studies, where “Undecided” was selected, the data will be changed to “No” collectively. Research that corresponds to data bulk changes will be sent to the registrar’s email. Sponsors can change it to “Yes” if their IPD sharing plan changes.
  • Modifications to input items and changes to existing registered research data are expected further.
  • Detailed information can be accessed through Announcements (nih.go.kr)

April 2021: Republic of Korea Regulatory Update

Notice of Temporary Suspension of the Functions of CRIS (Primary Registry of Korea) due to Homepage Renewal Work

Clinical Research Information Service (CRIS) published a notice on April 20,  2021. In the context of the same:

  • Due to the renewal of the Clinical Research Information Service (CRIS) website, functions related to clinical research registration are temporarily suspended (until April 22, 2021).
  • The functions of creating, submitting, supplementing, registering, and renewing clinical research are temporarily suspended. Other clinical research inquiry functions are serviced normally.
  • Modifications and changes related to input items are expected further.

January 2021: Peru Regulatory Update

Update on New Version of Peruvian Registry of Clinical Trials (REPEC)

Peruvian Registry of Clinical Trials (REPEC) published a notification (COMMUNICATION N ° 002-2021-OGITT / INS) on January 28, 2021. In context of the new version of the REPEC, developed by the National Institute of Health (INS):

  • Any application for new registrations (Sponsor/OIC registration, Research Center registration, Ethics Committee registration, clinical trial authorization), must be made through the newly enabled REPEC Platform.
  • The previous REPEC platform will continue to record amendments, reports of adverse events, progress reports, deviations, among others, as well as changes in the conditions of authorization of clinical trials authorized until 2020, with the exception of clinical trials that have as a research product “vaccine candidates” which must use the new REPEC platform.

January 2021: Peru Regulatory Update

New Version of Peruvian Registry of Clinical Trials (REPEC)

As per notification COMMUNICATED No. 001-2021-OGITT/INS, published on January 06, 2021, the National Institute of Health (INS) has developed a new version of the REPEC that facilitates the searches, visualization and registration of data related to clinical trials carried out in Peru, whose objective is to serve as a source of primary information regarding clinical studies with pharmaceutical type research products and medical devices.

The General Office for Research and Technology Transfer – OGITT is responsible for the Peruvian Registry of Clinical Trials – REPEC, which is an online information system developed in its first version in 2006, after new technological changes at a global level, the INS publishes a new version of REPEC, which can be accessed through the following link https://repec.ins.gob.pe/.

The content of the new REPEC conforms to the standards set in the international platform for clinical trials registries of the World Health Organization regarding content, quality, validity, access, technical capacity and administrative profiles.

As of January 01, 2021, all requests for procedures related to new clinical trials must be registered in this new virtual platform of REPEC. Short and instructive tutorial videos have been made available to help the users.

All Sponsors and OICs are encouraged to register in the new REPEC in order to provide them with their username and password so that they can make requests for new clinical trials.

For the presentation of any modification related to an active clinical trial, it must be presented in the previous version of the REPEC link.