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How Box 8-12 "Other" In The CIOMS Report Is Checked For Medically Significant Cases (Doc ID 2396616.1)

Last updated on DECEMBER 04, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms

Currently the Oracle® Argus Safety Reports Technical Reference Manual (Release 8.1.2) has the following entry for Box 8-12 of the CIOMS report (both International and Local):

OTHER CHECKBOX
Source case_event.sc_other
case form: events Seriousness Criteria "Other"
Common Profile Switch: Reporting|Expedited - CIOMS: CIOMS Form Selection
Format none
Notes This checkbox shall be visible in the CIOMS form if the Common profile swith “CIOMS Form Selection” is set to CIOMS Form(6 Seriousness Criteria). If it is set to CIOMS Form(4 Seriousness Criteria), then this checkbox shall be hidden from the box 8 – 12.
If the other checkbox is checked for any event, this field shall be checked. System has a check in place to ensure if Other checkbox is checked then Other text has to be entered.

This text does not reflect the true behavior of this field after the implementation of the following defect:

The existing text does not include that the criteria OTHER (sec 8+12) now gets checked when an event is marked as Medically Significant or required intervention or other and selected to display all 6 seriousness criteria in common profile switches.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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