PMDA (ACK) Number Does Not Populate In PMDA Information Tab After Receiving Error ACK
(Doc ID 2416386.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.1.1 to 8.2 [Release 8.1 to 8.2]Information in this document applies to any platform.
Symptoms
The initial PMDA E2B (R3) has been submitted and ACK number for the series of these reports is populated in case form > analysis > PMDA info tab.
After sending the follow-up report to PMDA the error ACK (ACK.B.r.6 is CR and ACK.A.4 is AR) is received without an ACK number.
In the case form > analysis > PMDA info tab, the PMDA (ACK) number for the series of these reports has been removed and it is a blank field now.
Note:
Although the "PMDA (ACK) Number" is a blank in the PMDA info tab, the next follow-up report can be generated with PMDA (ACK) Number.
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Steps:
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1. Transmit and submit the initial PMDA E2B (R3)
2. Receive normal ACK with PMDA ACK number
3. Confirm that this ACK number populates in analysis > PMDA info tab
4. Schedule the follow-up report
5. Transmit the report
6. Received error ACK without ACK number (ACK.B.r.6 is CR and ACK.A.4 is AR)
7. Confirm that ACK number disappears from analysis > PMDA info tab
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |
| References |