1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. PMDA E2B(R3) and Paper Form updates

PMDA E2B(R3) and Paper Form updates

Summary

PMDA E2B(R3) and Paper Form updates

Description

PMDA published the updated guidance for investigational reporting on Aug 31, 2020.

Based on the updated guidance, Oracle Argus Safety has been enhanced as follows:

Case Form updates

  • In Study cases, you can capture listedness data for all non-company study drugs on the Events > Event Assessment tab. The non-company study drugs displayed in the Event Assessment screen are as per the existing functionality to capture causality for both WHO drug and J drug.
  • In Study cases, the non-company study drugs are displayed in the PMDA tab and Comments subtab. All the applicable fields on the PMDA tab, Drug Information section and Comments subtab are applicable for the non-company study drugs as well.

Console updates

  • A new field, Medicinal Product Name, has been added to the Argus Console > Business Configurations > License screen. This is a Japan specific field and is used to transmit the investigational products for the DC or DD reporting category in G.k.2.2. This configuration could be used in specific use cases as per the PMDA guidance if:
    • The drug has multiple CCNs (Clinical Compound Numbers).
    • It is used for different studies due to a different route of administration.
    • The active ingredient is approved in JP.
    • It is a foreign CT report.
  • A new drop-down field, Test Drug Type, has been added to the Argus Console > Studies Configuration > J data entry with the following values: Blank, Main Test Drug, Test Drug, Other than Test Drug. This field can be used to configure the type of drug as required for PMDA reporting by using this configuration in the advanced condition SQL queries for reporting rules.
  • The Allow multiple reports for Investigational Drugs check box on the Argus Console > Code Lists > Argus > Reporting Destination > EDI tab has been renamed to Allow multiple reports for Investigational Drugs (Clinical Trial). The reporting categories applicable to this check box are DA, DB, DC, DD. This option needs to be unchecked as per the updated guidance for investigational reporting.
  • A new check box, Allow multiple reports for Investigational Drugs (Research and Measure), has been added on the Argus Console > Code Lists > Argus > Reporting Destination > EDI tab. The Reporting categories applicable to this check box are DE, DF, DG. This option needs to be checked so that multiple reports are scheduled based on drug for cases reportable to PMDA.

Reporting updates

  • The Allow WHO Drug reporting check box in the Argus Console > Code Lists > Argus > Reporting Destination has been renamed to Allow WHO Drug / J Drug reporting. Select this option for PMDA agency and it automatically schedules reports for WHO drug or J drug in a study case if it becomes reportable.
  • The Argus Console > Business Configuration > Studies > Study Reporting section has been enhanced to automatically schedule reports for the Japan reporting rules configured in this section when the PMDA agency has the Allow WHO Drug / J Drug reporting option set.
  • The PMDA E2B(R3) report has been enhanced to support the updated guidance. For more information, refer to the ArgusInterchange84_PMDA E2B (R3) Export Import Mappings.xlsx mapping document.
  • The PMDA E2B(R3) paper report has been enhanced to support the updated template (dated March 31, 2022) published by PMDA. For more information, refer to the PMDA E2B R3 Form - Mapping.xlsx mapping document.

Other updates

The following minor PMDA guidance updates, which are already handled by knowledge articles, are incorporated:

  • ER 27983031 - D.9.4.r.1b validation error when generating PMDA E2B R3 report
  • ER 28580229 - Update conformance rules for J2.5.k and J2.6.k when J2.4.k = 5 (not applicable)
  • ER 27234225 - Show all data of PMDA E2B R3 G.k.4.r.4
  • ER 28291094 - PMDA R3 guidance updates – Codelists
  • ER 28107639 - Updates to allowed values for Dose, Strength, Lab test units
  • ER 29428415 - Validations for PMDA E2B(R3) elements to be added that does not allow Future date
  • ER 29454686 - PMDA R3 validation for element C.5.2 [studyname] to be triggered in specific scenario
  • ER 31477598 - Transmit only Primary reporter country (C.2.r.3) for PMDA R3 Research and Measure reports
  • ER 29621135 - For investigational unapproved license, do not transmit G.k.3.1/G.k.3.2

Parent topic: Enhancements to Oracle Argus Safety