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Validations for 'Mandatory for Completion Report' missing for J2.10, J2.11 ,H.1, H.2 and H.4 in PMDA Out Of The Box Profile (Doc ID 2463584.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.0 and later
Oracle Life Sciences Argus Safety - Version 8.0 and later
Oracle Life Sciences Argus Safety Japan Cloud Service - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

Validations for 'Mandatory for Completion Report' are not getting logged when the report is marked as completed for below DTD elements in PMDA Using An Out Of The Box Profile:

 

J2.10 (MHLWADMICSRCOUNTERMEASURES)

J2.11 (MHLWADMICSRREPORTTIMESEVENT)

H.1    (NARRATIVEINCLUDECLINICAL)

H.2     (REPORTERCOMMENT)

H.4    (SENDERCOMMENT)

Cause

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In this Document
Symptoms
Cause
Solution
References


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