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ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS Returns Validation Errors When Protect Confidentiality Is Checked. (Doc ID 2787440.1)

Last updated on JUNE 29, 2021

Applies to:

Oracle Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.

Symptoms

When using the msg profile 'ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS' we are unable to open the report when Patient Protect Confidentiality is checked.
If it is unchecked then it is working fine and displays all patient information in report.

When generating the report manually with the Patient Protect Confidentiality checked, the following errors are returned:

ERROR:

Value of D.5[PATIENTSEXR3] is required if C.1.3[REPORTTYPE] = 2 (Report from Study)
That is, for Clinical trial ICSRs
Null flavor is not allowed for Clinical Trial ICSR

Value of D.2.2a[PATIENTONSETAGE] and D.2.2b[PATIENTONSETAGEUNITR3] are required if
C.1.3[REPORTTYPE] = 2 (Report from Study)
That is, for Clinical trial ICSRs



Cause

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In this Document
Symptoms
Cause
Solution
References


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