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KI-81

MIC references FDA instead of EMA specifications

Key/Summary

KI-81 MIC references FDA instead of EMA specifications

Status

Done

Created

04/21/2022

Updated

08/31/2022

Description

MIC is, and has always been, built and validated against EMA/ICH E2B(R3) specifications. Current and previous versions of MIC have incorrectly referenced FDA specifications.

EMA specifications: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-individual-case-safety-report-icsr-implementation-guide_en.pdf

EMA XSD: http://eudravigilance.ema.europa.eu/XSD/multicacheschemas/MCCI_IN200100UV01.xsd

Impacted Capabilities

Inquiry Management

Affected Apps

Medical Information Cloud - Classic

Medical Information Cloud - Lightning

Affects Versions

V9, MIC V10, MIC V11

Fix Version

V12

Steps to Reproduce

  1. Enable E2B generation. Reference https://help.komodohealth.com/mic/en/inquiry-management-module/core/e2b-r3--generation.html#enablement.

  2. Create a new Adverse Event in an Interaction.

  3. Click Generate E2B.

  4. Validate the generated file against the XSD.

The validation fails because the wrong XSD is referenced in the XML header. A manual validation against the EMA XSD should succeed.

Workaround

The XML header will correctly reference the EMA XSD instead of the FDA XSD in MIC v12. In the meantime, to customize the manner in which current E2B XML documents are generated, reference https://help.komodohealth.com/mic/en/inquiry-management-module/core/e2b-r3--generation.html#customization.