PMDA C.1.6.1.r.2 Attachments Displays Again In Follow-up E2B
(Doc ID 2920139.1)
Last updated on JANUARY 11, 2023
Applies to:Oracle Argus Safety - Version 8.4 and later
Information in this document applies to any platform.
In a certain scenario, the same C.1.6.1.r.2 document information in the previous report displays again in the follow-up PMDA E2B.
C.1.6.1.r.2 document information should not populate in the follow-up report when Japan MKT license is different from the previous report.
Because the document information has not been changed after submitting the report. In this case, only C.1.6.1.r.1 <document> should populate in the follow-up report.
- The case has several Japan MKT license (say Japan MKT 001 and 002)
- In the additional information tab, the attachments for E2B is uploaded
- The "Allow multiple reports for Marketed Drugs" is unchecked in codelist : reporting destination > EDI info tab
- Open the case
- Go to the product tab
- Confirm that at least 2 Japan Marketed license (suspect drug) exist in case product tab
- In the additional information tab, confirm that there is the attachments for E2B
- Go to Enter the mandatory value for PMDA E2B
- Lock the case
- Schedule initial PMDA E2B for Japan MKT 001
- Generate the final report
E.g., the following C.1.6.1.x information displays in the initial E2B.
- Close the case
- Transmit the initial PMDA E2B
- Receive ACK
- Open the case
- Confirm that report status shows as "Submitted" and ACK information displayed
- Unlock the case as significant info
- In 1st product tab for Japan MKT 001, update the case as this suspect drug is no longer reportable to PMDA
For example, change the product type as Concomitant or make non-SUSAR and so on
- Schedule follow-up#1 for Japan MKT 002
- Save the case
- Click Draft link for follow-up#1
E.g., the following C.1.6.1.r.2 information displays again in f/u#1 E2B.
C.1.6.1.r.2 information should not populate here because this attachment information is already provided/submitted in the previous report.
In this case, only C.1.6.1.r.1 <document> information should populate in the follow-up report.
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