ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS Returns Validation Errors When Protect Confidentiality Is Checked.
(Doc ID 2787440.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.3 and laterInformation 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
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
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 |