Conformance Rules for Mandatary fields H.4 and J2.10 elements for PMDA ICSR Does Not Work
(Doc ID 2444881.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan Cloud Service - Version 8.0 and laterInformation in this document applies to any platform.
Symptoms
In PMDA OOB Profile, Conformance Rules does not work for mandatory DTD elements
H.4 (SENDERCOMMENT)
J2.10 (MHLWADMICSRCOUNTERMEASURES)
If data for these values are missing in case form, which cause not to transmit these DTD elements and receiving error ACK from PMDA concerning H.4 and J2.10 for the marketed report, while having no validation error informed in Argus.
Steps to Repeat:
----------------
1) Create a new case.
2) Enter data for ICSR R3 for case.
3) Schedule ICSR R3 for PMDA.
4) Click Draft link of ICSR. ICSR Viewer opens. H.4 and J2.10 exist on Decoded view.
5) Removed data from H.4 and J2.10 elements from case.
6) Click Draft link of ICSR. ICSR Viewer opens. H.4 and J2.10 do not exist on Decoded view.
Cause
To view full details, sign in with your My Oracle Support account. |
|
Don't have a My Oracle Support account? Click to get started! |
In this Document
| Symptoms |
| Cause |
| Solution |
| References |