Evaluation/Investigation Code Information Coding

Previously Evaluation/Investigation Code Information were part of the MW Info tab, and in the Oracle Argus Safety 8.2.2 Release Evaluation/Investigation Code Information is moved from MW Info to Product > Device Tab > Evaluation/Investigation Code Information.

• Evaluation/Investigation Coding is based on Harmonized codes where an FDA Code has a corresponding IMDRF Code. Therefore Evaluation/Investigation coding is required to be handled considering both US and Europe regions.
• For a Final MIR report and Combined Initial & Final MIR Report to be generated, there needs to be at least one Method/Type, Result/Findings and Conclusion available. It is recommended that the data entry guidelines are updated to ensure that for a Case which requires MIR Report to be Scheduled, Evaluation/Investigation Codes is Mandatory for Final and Combined Initial & Final MIR Reports.