The following are reference documents that will be helpful to you as you use the EudraVigilance system and take the EudraVigilance training course.

In particular, prior to attending the training course, you should be familiar with the ICH E2B(M) guidelines and the ICH E2B(M) Q&A document.

• ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting [PDF]
• ICH E2B(M) - Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for transmission of Individual Case Safety Reports [PDF]
• ICH E2B - Implementation Working Group Questions & Answers R5 3 March 2005 [PDF]
• ICH E2D - Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting [PDF]
• ICH M1 MedDRA Term Selection: Points to Consider - Release 3.2, MedDRA version 6.1 [PDF]
• ICH M2 - Electronic Transmission of ICSRs Message Specification: DTD version 2.1 [PDF]
• ICH M2 Recommendations
  • General 1.1 - Procedure for Recommendations [PDF]
  • General 1.2 - Gateway Recommendation for the Electronic Transfer of Regulatory Information (ESTRI Gateway) [PDF]
  • General 1.3 -Core Standard Set [PDF]
  • Physical Media 2.1 - Floppy Disks [PDF]
  • Physical Media 2.2 - CD-ROM [PDF]
  • Network 3.1 - Messaging [PDF]
  • Security 4.1 - Secure EDI Transmission over the Internet (SMTP/MIME) [PDF]
  • Format 5.1 - Electronic Document Format [PDF]
  • Format 5.2 - SGML DTD Electronic Format for the Exchange of ICSRs (E2B Message) [PDF]
  • Format 5.3 - EDI Header Specification for the E2B Message [PDF]
• Technical Documentation - EudraVigilance Human Version 7.0 Processing of Safety Messages and ICSRs [PDF]
• Volume 9A Implementation Questions & Answers Version 1.2 [PDF]