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When Will Fix For Bug 35955139 be Implemented (Doc ID 2996175.1)

Last updated on JANUARY 05, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.4 and later
Information in this document applies to any platform.


Is there an estimate for when Internal Bug 35955139 : EMA Test Case Scenarios will be fixed

Test case 6:

Literature with attachments: In this scenario, the concern is with Dosage latency time.

G.k.9.i.3.1a    Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)
G.k.9.i.3.1b    Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)
Though in UI, we are entering it as '6 months' under Case Form-->Event-->Product Event Details-->Onset from First dose, system converts it to 183 days which is correct, but EMA wants it in months only. Kindly suggest how Argus is supporting standard EMA testing in this scenario?

Test case 9:

Time intervals: In this scenario, issue is with the drug assessment for a non-company drug.

EMA has given a non-company drug to be added and wants causality assessment to be done. In Argus, we can only do causality assessments for company drugs (configured drugs in console). If we add the drug given by EMA as company drug to add assessment, active ingredient will also get added (as it is a mandatory field) and EMA does not want the active ingredient tag (medicinal product) to be sent for that drug.



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