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Report is not Scheduled After Previous Nullification Report (Doc ID 2804990.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.3 and later
Information in this document applies to any platform.


After a Nullification Report has been sent for a case, when attempt to send a new Report after follow-up, no report is scheduled.

The issue can be reproduced at will with the following steps:

  1. Create a case with mandatory information required for EMA Submission.
  2. Go to Regulatory Reports tab
  3. Press the Auto Schedule button and confirm EMA E2B has been scheduled, submit the report.
  4. Unlock the case with significant follow up
  5. Go to additional information tab and change the value of E2B Company Number.
  6. Save the case
  7. Follow the steps in order to schedule the nullification report
  8. Select Reports → Compliance → Submitted.

  9. Search for the report to be nullified using the Case Number. The search result will be listed in the section Total Number of Rows.

  10. Left click on the Status icon of the report to be nullified and select Schedule Nullification.
  11. Enter the justification for nullification by selecting one of the options available in the Action Justification dialog and click OK
  12. Open the case and Go to the regulatory report tab
  13. Mark the nullification report as non submit.
  14. Add a new significant follow-up. click the auto schedule button, no EMA report gets scheduled
  15. Initial report is expected to be scheduled.




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