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Case With Submitted Report Does Not Populate In PADER Report (Doc ID 2771850.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.1 and later
Information in this document applies to any platform.

Symptoms

There is a case which has the initial receipt date (e.g., 15-APR-2021) and E2B has already submitted on submitted date (e.g., 20-APR-2021 19:07).

This case with the submitted report does not populate in PADER report (e.g., reporting time frame is between 10-APR-2021 and 20-APR-2021).

 

Steps:

1. Create a new case with initial receipt date as 15-APR-2021

2. Enter the mandatory value for FDA E2B

3. Schedule initial FDA E2B

4. Lock the case

5. Generate the final report

6. Close the case

7. Transmit and submit the report

8. Open the case and go to the regulatory report tab

9. Confirm that the report status shows as "Submitted" and the submitted date is populated as "20-APR-2021 19:07"

10. Go to (menu) reports > Periodic Report > NDA

11. Create a new PADER report as follows:

      - (X) Case Receipt Date : (From) 10-APR-2021 (To) 20-APR-2021

12. Save the report template

13. Print this report

The case with the submitted report does not populate in PADER report.

Cause

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In this Document
Symptoms
Cause
Solution
References

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