Handling of Attachments as per PMDA E2B R3 Data Element List_v3.1.4 - Steps to Perform in Argus (Doc ID 2832605.1)

Last updated on JULY 13, 2023

Applies to:

Purpose

PMDA (Pharmaceuticals and Medical Devices Agency) has published updated guidance on 31-Aug-2020 for E2B R3 Investigational reporting regulations as GCP (Good Clinical Practice) and other minor updates.

The revised guidance published by PMDA (as of 2020/09/01) is:

• Data element lists v3.1.4
  
• Check rules v3.1.6
  
• Reference Instance v3.3
  
• J OID Code Lists v1.2

As per the updated guidance, one of the changes is that attachments can be submitted to PMDA for Research reports (category AE, AF, DE, DF), Corrective Action reports (AG, DG), Reports on quasi-drugs (BC), Reports on cosmetics (BD).

The purpose of this knowledge article is to provide steps to achieve this change. This is defined in the Data Element List_v3.1.4

The solution would be part of standard Argus from version after 8.2.3.1.

Useful Note:

Refer to below knowledge articles regarding PMDA INV reporting:

1. Changes in J OID Code Lists v1.2 - Steps to perform in Argus (Doc ID 2727558.1)
2. Changes in J2.4.k validation as per PMDA E2B R3 Checkrules_v3.1.6 - Steps to perform in Argus (Doc ID 2796744.1)

The complete solution for new PMDA INV guidance requires a lot more updates like sending causality/listedness for all products in a study case including non-company products which will be part of a standard Argus release.

Oracle is working with Argus customers in Japan to finalize the changes required in:

(i) Mapping logic updates
(ii) Validation query updates
(iii) Other updates (like codelist, case form etc.)

Scope

This document provides the steps to configure PMDA E2B R3 profile to enable transmission and import of attachments for Research reports (category AE, AF, DE, DF), Corrective Action reports (AG, DG), Reports on quasi-drugs (BC), Reports on cosmetics (BD).

Details

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