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***
Request clarification on how the standard PSUR (not PSUR BIP) determines the source for a case.
Steps to Reproduce:
- Create a new case.
- Set the Report source as SPONTANEOUS.
- Complete the case.
- Insert a follow-up (new version).
- Change the report source entry from SPONTANEOUS (S) to POISON CONTROL CENTER (P).
- Save the case.
- 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.
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