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eCF Releases Key Documents and Tools

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  • 20 November 2015
  • Author: Webmaster1
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eCF Releases Key Documents and Tools

eCF Releases several key "Members Only" documents and tools. 

The eCF is releasing 3 documents to eCF members via the eCF website “Members” area (un/pw required). Please feel free to download them and share with other members of your company.

 

  1. Draft White Paper:  Electronic Data Capture in Clinical Trials using Service Providers -- A method for ensuring the Investigator’s control of and continuous access to the CRF data reported to the sponsor when using an independent third party. This document is the result of countless hours of work by the eCF EDC Hosting Team and has been peer-reviewed by several industry groups and key opinion leaders. It will be presented/discussed with the EMA on 30-Nov-2015.
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers -- Tool for assessing the regulatory compliance of an i3P‐hosted EDC system used in clinical trials. This checklist is an outgrowth of work done by the eCF to identify key criteria for systems that provide source data for clinical trials (EHRCR Functional Profile (HL7, ANSI, EuroRec), and “eSRA” eSource Readiness Assessment Tool for clinical research sites. Please note: the eSRA is open to the public and can be accessed via www. Eclinicalnetwork.org).
  3. eCF Regulatory Resources Table – This table maps eClinical areas of interest (eg EDC, ePRO, eSubmission, etc) to appropriate regulatory documents from FDA, EMA, PDMA, ICH, other.  The table provides a link to obtaining the document via the internet. This is a working document and will be updated as the eCF REG becomes aware of new documents.
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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

Read more
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