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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

In November 17, 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries to address some of major developments in technology, medical breakthroughs and business processes – taking into account unprecedented yet justified expectations by regulators, patients, investigators and caregivers.

The eCF webinar explored what was removed and discussed some of the opportunities and challenges presented by additions to the E6 text:

  • How to eliminate sponsor control over Investigator entries/Source data? Where did the contemporaneous investigator copy go and should we forget all about it?
  • How to develop and document risk-based approaches to monitoring in order to protect reliability of trial results (Data Integrity)? How to develop monitoring plans which describe the strategy, methods, responsibilities, and requirements for monitoring the trial?
  • CSV formally makes its way into GCP in a more prescriptive manner than ever before – too late, too little?

Slides used during the event can be downloaded by eCF members from the Members area of the website.

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Technology Showcase Webinar: How can a modern CTMS help you to ensure successful trial execution

Succeeding with CTMS – how can a modern CTMS help you to ensure successful trial execution
Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other eclinical systems can help ensure successful trial execution. This tech showcase will highlight what you can expect from a modern CTMS including successful integration ideas and techniques.

Presented by: Jan Klint Nielsen, BSI Business Systems Integration AG

Available to staff from eClinical Forum member companies only. For more information, please contact webmaster3@eclinicalforum.org 

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