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EU Clinical Trials Regulation Impact on Argus Safety (Doc ID 2847119.1)

Last updated on FEBRUARY 07, 2022

Applies to:

Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.


 With the implementation of the EU Clinical Trials regulation* from 31 Jan 2022, sponsors of clinical trials are no longer required to submit SUSARs directly to European National Competent Authorities (NCAs) instead, they will be required to submit SUSARs centrally to the Clinical Trial Module of EudraVigilance (EVCTM). The European Medicines Agency will take on the responsibility of re-routing SUSARs to the NCAs via new functionality introduced in EudraVigilance.
Additionally, EU ICSR IG has been updated to be aligned with EU Clinical Trials regulation and the following changes are also required for SUSARs submitted to EVCTM:
1. Study Registration Number (C.5.1.r.1) requires a valid EudraCT number or unique EU trial number when the data element Study Registration Country (ICH E2B(R3) C.5.1.r.2) contains the value ‘EU’.
2. A valid EU Trial number should match an authorised number in the CTIS database and have the format YYYY-5NNNNN-XX-VV. In situations where a Clinical Trial has both a EudraCT number and an EU Trial number, just the EU Trial number should be provided.

The goal of this document is to provide recommendations to cope with the latest regulatory updates.
• Centralized SUSAR reporting to EVCTM
• Support of EU Trial number in SUSAR



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