J2.13.r.x items are Not generated in PMDA R3 ICSR for INV license on Spontaneous case
(Doc ID 2386519.1)
Last updated on MARCH 01, 2023
Applies to:
Oracle Argus Safety Japan - Version 8.1.2 and laterInformation in this document applies to any platform.
Symptoms
J2.13.r.x elements are not generated in PMDA R3 ICSR for INV license on domestic Spontaneous case.
Steps to Repeat:
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1) Create One products on argus console:
a. Product A - Investigational License with valid CCN.
2) Add the Product A to a Study and add configure the Investigational License as the "Primary License".
3) Book in a domestic spontaneous case with Product A and do the minimum case data entry to generate Investigational Report.
4) Schedule PMDA R2 & R3 ICSR report for the same investigational License.
5) When generating both R2 & R3 report:
R2 report will contain the Data for J.12 - MHLWABSTRACTOFSTUDY
R3 will not have any values for J2.13.r- MHLWABSTRACTOFSTUDY
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |