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Issue With NDA Periodic Report - 15 Day Submitted Reports With System Organ Class Section - Date Populated instead of System Organ Class (SOC) (Doc ID 1350818.1)

Last updated on MARCH 07, 2016

Applies to:

Oracle Argus Safety - Version 4.2.1.3 and later
Information in this document applies to any platform.
***Checked for relevance on 30-Sep-2014***

Symptoms


Oracle Argus Safety version 4.2.1.3

In the NDA periodic report that is generated as Draft or Final, the first page of the 15 day submitted reports by system organ class section has a date populated instead of system organ class. Sometimes cases are listed twice with a date instead of SOC.

Example below:



Steps to Reproduce:

  1. Create a product with a U.S. marketed drug license
  2. Create a basic new case that contains the product from step 1 and one diagnosis event (for example: pyrexia)
  3. Lock the case and schedule, generate and submit a MedWatch report for the license created in step 1.
  4. Configure an NDA report for the license configured in the step 1 such that the report submitted in Step 3 will appear in the 15-day submitted section of the NDA report.   Note:  The NDA report must be configured to 'List cases only once, under the primary event system organ class' under the listing options section of the Line Listing tab. 
  5. Run the report.
  6. Verify the report is correctly showing the case under the correct body system and submission dates in the 15 day submitted section.
  7. Add a new diagnosis event (for example: hives) and re-arrange it to make it the event primary.
  8. Run the NDA report again.
  9. Verify the report is correctly showing the case under the correct body system and submission dates in the 15 day submitted section.
  10. Observe that the output on the 15-day submitted section may show either System Organ Class: 'IND_Body_sys' or some date may appear (per example above)

Cause

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