In order to ensure compliance with international standards in clinical trial safety reporting, our institution has developed the national “SUSAR Module” as a sub-module of the Clinical Trials Module. This module will enable the collection, recording, creation of a national database, and analysis of individual safety reports generated in clinical trials conducted in our country.

The National SUSAR Module has been developed in accordance with the requirements of ICH E2B(R3): Electronic Transmission of Individual Case Safety Reports and EU Directive 536/2014. Within this scope, the “Guidelines on Safety Reports in Clinical Trials” have been updated and published, entering into force on May 15, 2026.

Notifications regarding SUSARs occurring in clinical trials conducted in our country can be submitted in XML format via the “SUSAR Module” or in PDF format using the CIOMS form via the “Clinical Trials Module” until July 1, 2026. From July 1, 2026 onwards, notifications will only be accepted in XML format via the “SUSAR Module”. 

To ensure the uninterrupted and controlled reporting processes for SUSARs occurring abroad, these reports must be submitted in 6-month periods as sequential lists through the Clinical Trials Module. The attached sample sequential list must be prepared in English, with all relevant fields filled out completely, separately for each research product. The prepared lists should be sent to kagb@titck.gov.tr, specifying the research product name and date range in the email subject line. Furthermore, these lists must be submitted to the Institution in PDF format via the EBS-ESY Clinical Trials Module, selecting the application document type “Safety Report: Serious Unexpected Suspected Adverse Reaction (SUSAR) 6-month Sequential List Report”. A single report per research product is sufficient for this process.