Postpone Use of EDQM Terminologies for Dose Forms and Routes of Administration in Argus 8.2.3.1 Until EV Production Go-Live
(Doc ID 2862114.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.3.1 to 8.2.3.1 [Release 8.2]Oracle Life Sciences Argus Interchange - Version 8.2.3.1 to 8.2.3.1 [Release 8.2]
Information in this document applies to any platform.
26-May-2022: Updated steps in section 'Modifying the R3 Profile' for Import logic
Goal
Argus Safety release 8.2.3.1 provides features to submit European Directorate for the Quality of Medicines (EDQM) terminologies for Dose Forms (DF) and Routes of Administration (ROA) for ICSRs in E2B(R3) messages stated in the ICH User Guide v 1.1.
It has been stated that the EV production environment is not yet ready to receive EDQM Terminology in ICSR E2B (R3) reports.
The purpose of this article is to provide recommendations on the configuration updates required in Argus Safety release 8.2.3.1 not to send EDQM TermIDs in EMA E2B(R3) until EV production environment is ready to receive EDQM terminologies for DF and ROA for ICSRs in E2B(R3) message until Jun 30th 2022.
It also explains the steps to revert the changes once EV production environment is ready to accept EDQM terminologies.
NOTE: This article is applicable only to Argus version 8.2.3.1 and only until Jun 30th 2022.
Solution
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