Last updated on JUNE 16, 2017
Applies to:Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.
Not being able to assess event terms with LLT instead of PT has an impact on the R3 requirements to report terms with corresponding LLTs
Argus only supports auto-labeling with datasheets of PT lists; however it is required to be able to do this with datasheets with LLTs. This enhancement is per ‘datasheet’ level so that datasheets used for EMA and FDA can be set up with PTs (R2 requirements) and datasheets used for PMDA can be set up with LLTs (R3 requirements).
If this ER would be implemented, case processing users will become able to assess listedness of events using Argus auto-labeling functionality
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