Please join your peers on either March 26 (8pm GMT) or March 28 (8am GMT) to watch as user extraordinaire and forum legend @"lindsay.stevens" demonstrates OpenClinica Insight.

See preview and register at https://openclinica.com/insight-webinar

Insight makes it easy to ask questions of ALL of your clinical and operational data and visualize answers via interactive reports and dashboards. The idea is simple, but the results are powerful: ask your questions, choose your visualizations, then return often for updated, interactive results that link you to all of the underlying data.

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: 403 ✭✭✭
    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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