NDA 15 Day Section Ignores E2B Submitted Reports With Message Type As Null
(Doc ID 1545410.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 6.0.5 to 7.0.1 [Release 6.0 to 7.0.0]Information in this document applies to any platform.
***Reviewed for currency: 07-Jan-2015***
***Reviewed for currency: 15-AUG-2017***
Symptoms
Some of the submitted reports are not appearing in the Line Listing of 15 Day Submitted Reports section of the NDA Report
Steps to Repeat:
1. Create a case and schedule an E2B report using active moiety reporting rule and submit it to FDA
2. Create a followup report and submit the report
3. Create a NDA report so that the case created in step 1 is included
4. Generate the NDA report
5. Observe that report shows only the initial report in the Line Listing of 15 Day Submitted Reports section of the NDA Report
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |