Summary of ICH revision R2

For those of you interested: ICH E6 Revision 2 [R2] has been released for comments. That's a lot to read, but a very concise pdf with the changes is available at http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Online_Articles/ICH_E6_rewritten_to_reflect_recent_GCP_findings.pdf
In it is a paragraph on "Electronic Systems and Data Handling", page 8 and further. All interesting stuff to read, including the section covering the "certified copy (1.11.1)" about which there was a discussion in this forum last year : https://forums.openclinica.com/discussion/15244/ema-compliance
Gerben Rienk

Comments

  • lindsay.stevenslindsay.stevens Posts: 391 ✭✭
    via Email
    Thanks for sharing this Gerben. Glad to see its all pretty sensible advice.
    Particularly part 1.60.1 and the explicitness if 5.5.3 b) about system
    validation.
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