ICH PSUR: PBRER Section 6.2 and 6.3 Not Getting Sent in Email as Attachment
(Doc ID 2134397.1)
Last updated on MAY 21, 2021
Applies to:Oracle Argus Safety - Version 8.0.1 and later
Information in this document applies to any platform.
Oracle Argus Safety Version : 8.0.1
While generating the ICH PSUR report, not receiving the PBRER sections 6.2/6.3 separately as attachments via email (as per Oracle Argus Release notes).
There are no errors or warnings reported via the Argus UI.
The expectation is that attachments for PBRER should be emailed.
- Create an ICH PSUR periodic report
- Opt to include PBRER sections 6.2 and 6.3 inclusion criteria
- Click on [Print] to generate report with a valid email address/reporting destination
- Check report generates OK (Via background periodic reports)
- No email notification is received by designated email user, with attached sections 6.2 and 6.3
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