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

WHO WE ARE

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


News from the eCF

Login to also view news for Members.

EDC Hosting Team Releases Final Documents

Documents Available

EDC Hosting Team Releases Final Documents
The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

The White Paper focuses on web/cloud based EDC utilizing service providers and the delivery of hosting or application management services in a manner that prevents exclusive sponsor control over site entered data. The concept of an investigator “zone of control” is described to assist the ongoing governance of data by respective sites. Such control is facilitated via continuous investigator access to data; use of independent third parties (the i3P); an appropriate documentation framework and task delegation/control. The eCF proposal is not mutually exclusive of other methods of meeting regulatory expectations.

Documents to download

Print
Tags:
Rate this article:
5.0

Theme picker

Not a member?
Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

«September 2019»
MonTueWedThuFriSatSun
2627282930311
2345678
9101112131415
16171819202122
232425
9/25/2019 UTC
87

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.

Read more
26272829
30123456

Upcoming events Events RSSiCalendar export