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Unexpected NDA MedWatch Reports Generated In Case (Doc ID 2519421.1)

Last updated on AUGUST 15, 2019

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.


Several NDA reports have generated a NDA MedWatch report for cases even though the FDA 3500A/VAERS Forms is unchecked.

Please provide instructions on getting rid of these records.

When the NDA report is marked as submitted these MedWatch records are not being marked as submitted.
This is causing issues with routing rules because it is expected that all reports within the case are to be submitted.

1. Create a NDA report that at-least generates one case in the one of the part (Serious-Listed, Non Serious-Listed and Non Serious-Unlisted cases) and make sure "Tab 1: FDA-3500A / VAERS Forms" is un-checked.
2. Generate the final PDF for that NDA report.
3. Check the report for the case got generated in step 1.
4. Go to that case Regulatory reports tab and save the case, you can see Medwatch report is generated for the FDA.




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