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Cases are not Appearing Under Correct SOC in the Line Listing Section of the IND Periodic Report (Doc ID 1271046.1)

Last updated on DECEMBER 03, 2019

Applies to:

Oracle Argus Safety - Version 4.2.2 and later
Information in this document applies to any platform.

Symptoms

Cases are listed under wrong System Organ Class (SOC) group in the line listing of the IND Periodic Report when the check box "Create a Sub Report for Death Cases" is checked under Line Listing tab of the report configuration.

Steps to Repeat:
1. Create the following 4 clinical trial cases using an open label study
Case 1: Event Verbatim [Preferred Terms]: CONSTIPATION [CONSTIPATION],
             SOC: Gastrointestinal disorders
             Event Seriousness Criteria: Medically Significant

Case 2: Event Verbatim [Preferred Terms]: uncontrolled pain (chest-non-cardiac) [NON-CARDIAC CHEST PAIN],
            SOC: General disorders and administration site conditions
            Event Seriousness Criteria: Medically Significant

Case 3: Event Verbatim [Preferred Terms]: rash [RASH],
             SOC: Skin and subcutaneous tissue disorders
            Event Seriousness Criteria: Death

Case 4: Event Verbatim [Preferred Terms]: Uncontrolled pain (chest-non-cardiac) [NON-CARDIAC CHEST PAIN],
            SOC: General disorders and administration site conditions
            Event Seriousness Criteria: Death

2. Configure an IND report with the following options:
a. Inclusion Criteria Tab
- Select Case Receipt Date and Use Current Version
- Check Domestic Cases and Include Unlocked Cases check boxes

b. Line Listing Tab
- Report Options: Select "Report All Events"
- Listing Options: Select "List Cases only Once, under the primary event system organ class (SOC)"
- Create a Sub Report for Death Cases

3. Run a Draft Report

4. Observe that Case 1 and Case 2 appears under "Gastrointestinal disorders" SOC in Line Listing Serious Reports section. Case 2 should have been appeared under "General disorders and administration site conditions" SOC.


Cause

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In this Document
Symptoms
Cause
Solution


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