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PMDA ICSR Validation error report will transmit via EMAIL (Doc ID 2163229.1)

Last updated on FEBRUARY 18, 2019

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 and later
Information in this document applies to any platform.


When transmitting the PMDA paper report via Email, PMDA ICSR validation report was transmitted instead of the actual PMDA Paper report.




Steps to reproduce:

1. Open the blind study case
2. Go to the regulatory report tab
3. Schedule PMDA paper report with "Blind study product" flag
4. Save and Lock the case
5. Click the final link of PMDA paper report
6. PMDA ICSR validation error report (PDF file) appears

7. Unlock the case
8. Fixed the data
9. Save the case
10. Lock the case

11. Click the final link of the PMDA paper report
12. PMDA Paper report was displayed and generated properly without any error
13. Save the case

14.Send the report via Email
15. Check the received email and open the attached PDF File

This is the PMDA validation report that was displayed at step6. The generated final report at step12 supposed to attache the email.




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