Update: This article was originally published in 2018 to explain key features introduced with Oracle Argus Safety 8.1.1. It is retained as a historical reference for this version. ClinSkill has since upgraded its Oracle Argus Safety environment to a newer version. For current information, see Oracle Argus Safety upgraded to 8.4.4.
What’s New in Oracle Argus Safety 8.1.1?
Oracle Argus Safety 8.1.1 introduced important updates to the Argus Safety platform. When this version was released, one of the common questions from learners was how it differed from Oracle Argus Safety 8.1. In addition to bug fixes and general improvements, two significant areas of change were support for E2B(R3) and WHODrug B3/C3.
Official technical documentation for this release is available in the Oracle Argus Safety 8.1.1 documentation library.
E2B(R3) Electronic Safety Reporting
All companies that currently report safety data to regulatory agencies or partners using E2B will be required to adopt the new E2B(R3) format beginning in 2019. If you will be receiving cases from the European Medicines Agency (EMA) via the new EudraVigilance website, you will only be able to download these reports in R3 format. If you don’t upgrade to 8.1.1, you will need to use a backwards and forwards conversion (BFC) tool, which can transform the R3 file into an R2 file that you will then be able to import into Argus.
WHODrug B3/C3 Updates
The Uppsala Monitoring Centre (UMC) will be releasing WHODrug B3/C3, the new version of the dictionary, which will increase the length of two fields: CMCLAS and CMDECOD. This will help future-proof the dictionary. According to the UMC, the new version will be available alongside the current B2/C2 version until September 2018, at which point the new version will be the only option. While you will be able to load the new dictionaries into 8.1.1, Oracle said it will not be creating a patch for older versions.
ClinSkill continues to provide Oracle Argus Safety training through its pharmacovigilance and Argus Safety programs. Eligible software-inclusive programs provide learners with hands-on access to ClinSkill’s current Oracle Argus Safety environment.