EudraVigilance XCOMP Release Notes - European Medicines Agency
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EudraVigilance XCOMP Release Notes - European Medicines Agency
EVWEB These release notes summarise a few technical issues in EVWEB with a potential impact from a user perspective. Fixes for these identified issues are underway and will be deployed at the latest at the time of the go-live on 22 November 2017. Ad interim and where possible, a workaround has been proposed.
1. Acknowledgment messages are not sent if the ICSR contains an attachment over 15 MB or if the attachment contains special characters. a.
Proposed workaround: Send messages with one or more attachments which are in total up to 15 MB; avoid sending attachments containing special characters.
2. UTC Time zone offset is not stored in the database. a.
Proposed workaround: N/A
3. Files in the ICSR download section will not be available for downloading for up to 30 seconds after being displayed on the screen with status “complete”. a.
Proposed workaround: Wait 30 seconds before downloading a file after it loads to the screen.
4. Occasionally an error shows when importing a big size file (up to 20 MB). a.
Proposed workaround: Do not import big size files to EVWEB.
5. Test SUSAR files are being included in ICSR Download requests. a.
Proposed workaround: N/A
6. EudraVigilance business rules do not generate an error acknowledgment when study section data elements are missing from an E2B(R3) XML file for ICSRs with report type “Report from studies” a.
Proposed workaround: N/A
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7. It is recommended to use Google Chrome or Mozilla Firefox as preferred internet browser.
Points for your consideration: 1. Product data has been loaded for all registered MAH HQ organisations. The product is called “Product-L2A” and contains the substance “Substance-L2A”. Any ICSRs submitted with these products or substances will be accessible by all MAHs as L2A access. 2. Sample ICH E2B(R3) ICSR data has been uploaded in XCOMP for testing of the ICSR download functionality; for this purpose ICSRs can be requested by selecting the date range to cover 22 June 2017. 3. ICH regional data elements are not supported. Therefore ICSRs containing these non-EU regional data elements may not receive acknowledgements. Proposed workaround: Do not include non-EU regional data elements
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