Change J2.14.i Unknown_Known not to be transmitted - Steps to perform in Argus
(Doc ID 2851953.1)
Last updated on FEBRUARY 25, 2022
Applies to:
Oracle Argus Interchange - Version 8.2 to 8.2.3 [Release 8.2]Oracle Argus Safety Japan - Version 8.2 to 8.2.3 [Release 8.2]
Oracle Argus Safety - Version 8.2 to 8.2.3 [Release 8.2]
Information in this document applies to any platform.
Purpose
PMDA has published updated guidance for E2B R3 Investigational reporting regulations as GCP (Good Clinical Practice). As per the updated guidance, clinical trial reports should include details of tested medicinal products and also other medicinal products.
| Date | Guidance Documents |
| 31-AUG-2020 | • MHLW Head of Agency Notification • MHLW Two Managers Notification for E2B(R3) • PMDA Five Directors Notification for E2B(R3) • MHLW Manager Notification for J-DSUR |
| 09-DEC-2020 | • E2B(R3) Q&A • J-DSUR Q&A |
| 25-DEC-2020 | • PMDA Five Directors Notification for E2B(R3) |
| 30-JUL-2021 | • MHLW Head of Agency Notification • MHLW Two Managers Notification for E2B(R3) • PMDA Five Directors Notification for E2B(R3) • E2B(R3) Q&A |
| 07-FEB-2022 | • MHLW Two Managers Notification for E2B(R3) • E2B(R3) Q&A • J-DSUR Q&A |
To comply with the updated guidance, changes are required in E2B R3 report for study cases to be submitted to PMDA. In Argus, the list of changes includes mapping logic updates, validation updates, codelist updates, case form and report scheduling updates.
Scope
One of the mapping updates as per guidance documents published on 7-Feb-2022, the listedness can be transmitted in J2.11 element instead of J2.14.i element as per the current practice.
This KM article contains the steps to update J2.14.i element logic such that this element is no longer transmitted.
Details
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In this Document
| Purpose |
| Scope |
| Details |