Clarification On How PSUR Determines The Source Type For A Case (Doc ID 1083326.1)

Last updated on JANUARY 10, 2014

Applies to:

Adverse Event Reporting System - Version 4.6.1 and later
Information in this document applies to any platform.

***Checked for relevance on 10-JAN-2014***

Goal


AERS 4.6.1

Request clarification on how the standard PSUR (not PSUR BIP) determines the source for a case.

Steps to Reproduce:

  1. Create a new case.
  2. Set the Report source as SPONTANEOUS.
  3. Complete the case.
  4. Insert a follow-up (new version).
  5. Change the report source entry from SPONTANEOUS (S) to POISON CONTROL CENTER (P).
  6. Save the case.
  7. Generate the PSUR and check the report source as reported in the Case History section and in the Cumulative Serious Unlisted Cases section: note the values are different.





Solution

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