Usage of EDQM Routes of Administration (RoA) and Dose Forms (DF)

Summary

Oracle Argus is enhanced to comply with the ICH regulations.

Description

The International Council for Harmonisation (ICH) published the Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message user guide, which includes:

• Details about EDQM API to access Standard Terms.
• Details on how to migrate E2B(R2) Routes of Administration text and Dose Form Text to the EDQM Standard Terms.
• Recommendation to send EDQM Term ID and version for Dose Formulation(DF) and Route of Administration(RoA).

To comply with the regulations, the following Oracle Argus Safety components are enhanced or introduced:

• EDQM Standard Term Dictionary Load utility
• Argus Code List
• Report mapping

EDQM Standard Term Dictionary Load utility

A new menu option is added under Argus Console, in the Tools menu. Click Dictionary Management, and then choose EDQM.

The new UI allows you to:

• Load the EDQM Standard Terms database in Argus.
• Maintain a local repository for the EDQM Standard Terms database.
• Synchronize the Argus code list for RoA and DF.

This utility is available to cloud and on-premise customers.

The CRO multi-tenant environment:

• Is available to a default enterprise only.
• Is available only to users with a Global Admin role.
• Performs system level updates.
• Refreshes the code list for all tenants (enterprises) in a multi-tenant environment.

Argus Code List

The following updates are implemented:

Factory data	The EDQM terms are provided as part of factory data as per the Standard Term List published on July 21, 2021. For more information, refer to the eTRM document. The latest terms for RoA and DF along with the EDQM Term ID can be loaded using the Dictionary Management > EDQM Load Utility.
Console > Code List > Routes of Administration	The Administration Route length was increased to 60 AN characters for English and Japanese terms. The EDQM Term ID is associated with the Administration Route term.
Console > Code List > Formulation	The EDQM Term ID is associated with the Formulation term.

Report Mapping

• ICSR Export

  The mapping logic is updated along with the OID changes to implement the EDQM standard term functionality:

  Profile Template	Route of Administration Element	Dose Formulation Element
  ICH-ICSR V3.0 MESSAGE TEMPLATE ICH-ICSR V3.0 MESSAGE TEMPLATE – EMA ICH-ICSR V3.0 MESSAGE TEMPLATE – MFDS ICH-ICSR V3.0 MESSAGE TEMPLATE – NMPA	DRUGADMINISTRATIONROUTETEXT [G.k.4.r.10.1] DRUGROUTEOFADMINTERMIDVER [G.k.4.r.10.2a] DRUGROUTEOFADMINTERMID [G.k.4.r.10.2b] DRUGPARADMINISTRATIONTEXT [G.k.4.r.11.1] DRUGPARROUTEOFADMINTERMIDVER [G.k.4.r.11.2a] DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b]	DRUGDOSAGEFORM [G.k.4.r.9.1] DRUGPHARMADOSEFORMTERMIDVER [G.k.4.r.9.2a] DRUGPHARMADOSEFORMTERMID [G.k.4.r.9.2b]

  For an updated list of mappings for E2B(R3), refer to ArgusInterchange8231_E2B (R3) Export Mappings.xlsx.

• ICSR Import

  The ICSR Import mapping logic is updated for the following profile to decode DF and RoA based on the EDQM term ID:

  Profile Template	Route of Administration Element	Dose Element for RoA and Formulation
  ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA	DRUGROUTEOFADMINTERMID [G.k.4.r.10.2b] DRUGADMINISTRATIONROUTETEXT [G.k.4.r.10.1] DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b] DRUGPARADMINISTRATIONTEXT [G.k.4.r.11.1]	DRUGPHARMADOSEFORMTERMID [G.k.4.r.9.2b] DRUGDOSAGEFORM [G.k.4.r.9.1]

  For an updated list of mappings for EMA E2B(R3), refer to ArgusInterchange8231_E2B (R3) Import Mappings.xlsx.

• E2B Element Type changes

  The allowed values are cleared for the following elements:

  Profile Template	Elements
  ICH-ICSR V3.0 MESSAGE TEMPLATE ICH-ICSR V3.0 MESSAGE TEMPLATE – EMA ICH-ICSR V3.0 MESSAGE TEMPLATE – MFDS	DRUGROUTEOFADMINTERMID [G.k.4.r.10.2b] DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b]

For more information on configuration and reporting, refer to the EDQM Best Practices document.