| 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. 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. | | |