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NDA Report 'Index of Cases in Report' Prints Same Case at Multiple Categories Duplicately (Doc ID 2833301.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

NDA Report 'Index of Cases in Report' section prints same case at both 'Initial Serious Listed Cases'/'Initial Non-Serious Listed Cases'/'Initial Serious UnListed Cases'/'Initial Non-Serious UnListed Cases' and '15 day Submission Cases' categories duplicately.

Steps to Repeat:

  1. Create a new case with 1 product and 1 event.
  2. Enter data for the case for Initial E2B.
    Event: Serious / Related / Listed
  3. Schedule Initial E2B for an agency and generate the report.
  4. Submit the report.
    Event: Serious,Related,Listed / Report: Report State=Submitted
  5. Create a new NDA report and configure it to include the above case.
  6. Print Draft the NDA report.
  7. After the NDA report is generated, save the generated NDA report output PDF file.
  8. Open the generated NDA report PDF file and check the Index of Cases in Report section.
    --->The case appears at both 'Initial Serious Listed Cases' and '15 day Submission Cases' sections.

Cause

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In this Document
Symptoms
Cause
Solution
References


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