Negative ACK Received From EMA For Event Onset Date And Death Date
(Doc ID 2941642.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Interchange - Version 8.2.3.1 and laterOracle Life Sciences Argus Interchange Cloud Service - Version 8.2.3.1 and later
Information in this document applies to any platform.
Symptoms
User transmitted R3 XML file to EMA with DTD element D.9.1 i.e. PATIENTDEATHDATE as 20-OCT-2022 (in OOB design, Argus Safety system doesn't capture timestamp for death date in UI) and E.i.4 i.e. REACTIONSTARTDATER3 as 20-OCT-2022 17:23.
EMA rejected the file and sent negative ACK with reason being Event Onset Date (20-10-2020 17:23) is more than the Death Date (20-10-2020).
As per EMA business rules -
‘Date Value in Date of Start of Reaction/Event - E.i.4 must be <= the Date of Death - D.9.1’.
The same rule applies to Date of End of Reaction/Event [E.i.5] and Patient Birth date [D.2.1] also.
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |