NEWS FROM THE ECF

White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

  • 22 December 2016
  • Author: Webmaster1
  • Number of views: 2065
  • 0 Comments
White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

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.

The document is part of a 3 document set comprising:

  1. White Paper: Electronic Data Capture in Clinical Trials using Service Providers
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers
  3. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

Documents to download

Print
Tags:
Rate this article:
No rating
«August 2025»
MonTueWedThuFriSatSun
28293031123
eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

Read more
45678910
111213
Birds-of-a-Feather Round-table on eCOA Topics

Birds-of-a-Feather Round-table on eCOA Topics

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )

Read more
14151617
18192021222324
25262728293031
1234567

Upcoming events Events RSSiCalendar export