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  • Tokyo 3-4 December 2019
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  • Zurich 28-30 October 2019
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  • Peapack 14-16 October 2019
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  • Brussels 15-17 May 2019
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  • Danbury 8-10 April 2019
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  • Tokyo 5-6 November 2018
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  • Paris, France 23-25 October 2018
    Paris, France 23-25 October 2018
  • Philadelphia, USA 2-4 October 2018
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  • Princeton 1-3 May 2018
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  • Darmstadt, 15-17 May 2018
    Darmstadt, 15-17 May 2018

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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


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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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eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

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