What is the versioning policy for reporting ICH ICSRs?
• EudraVigilance (production environment, EudraVigilance post-authorisation module and Clinical Trial module) accepts reports using the current version of MedDRA and the one previous to it. • EudraVigilance (test environment, EudraVigilance post-authorisation module and Clinical Trial module) accepts reports using MedDRA Version 4.0 and later versions. • Retrospective reporting of ICSRs (Backlog reporting’) accepts MedDRA Version 4.0 or later versions. Please note that MedDRA versions are updated every six months (March and September). The MSSO does recommend organizations to follow the Best Practices document published on the MSSO Web site at http://www.meddramsso.com/MSSOWeb/Docs/clinicaltrialversioning.pdf, which is endorsed by the MedDRA Management Board and provides options and recommendations for the implementation and versioning for clinical trials.
