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:
- Create a case with mandatory information required for EMA Submission.
- Go to Regulatory Reports tab
- Press the Auto Schedule button and confirm EMA E2B has been scheduled, submit the report.
- Unlock the case with significant follow up
- Go to additional information tab and change the value of E2B Company Number.
- Save the case
- Follow the steps in order to schedule the nullification report
- Select Reports → Compliance → Submitted.
- Search for the report to be nullified using the Case Number. The search result will be listed in the section Total Number of Rows.
- Left click on the Status icon of the report to be nullified and select Schedule Nullification.
- Enter the justification for nullification by selecting one of the options available in the Action Justification dialog and click OK
- Open the case and Go to the regulatory report tab
- Mark the nullification report as non submit.
- Add a new significant follow-up. click the auto schedule button, no EMA report gets scheduled
- Initial report is expected to be scheduled.
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