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  • 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
  • Tokyo 4-5 December 2017
    Tokyo 4-5 December 2017
  • Wellesely, MA 16-18 October 2017
    Wellesely, MA 16-18 October 2017
  • BERLIN 26-28 SEP 2017
    BERLIN 26-28 SEP 2017
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  • NEW YORK 19-21 OCT 2015
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    NORTH WALES, PA 18-20 MAY 2015
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eCF Releases Key Documents and Tools

Partnering for Success

  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 9067
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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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11/5/2018 - 11/6/2018 UTC
63

AGENDA AVAILABLE: eClinical Forum Asia-Pacific 2018 Workshop in Tokyo, 5-6 November 2018

Our next meeting of the eClinical Forum Asia-Pacific will take place in Tokyo, 5-6 November 2018 and is kindly hosted by Boehringer Ingelheim - Japan. An outline agenda and registration details are available...

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6
11/5/2018 - 11/6/2018 UTC
63

AGENDA AVAILABLE: eClinical Forum Asia-Pacific 2018 Workshop in Tokyo, 5-6 November 2018

Our next meeting of the eClinical Forum Asia-Pacific will take place in Tokyo, 5-6 November 2018 and is kindly hosted by Boehringer Ingelheim - Japan. An outline agenda and registration details are available...

Read more
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11/7/2018 UTC
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Birds-of-a-Feather Discussion:  Industry Adoption of RBM after ICH-E6(R2)

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              Wed, Nov 17 2018 at UTC 16:00 – Presenter Ken Light, OmniComm Systems

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11/14/2018 UTC
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Birds-of-a-Feather Discussion:  Industry Adoption of RBM after ICH-E6(R2)

Date:    Wed, Nov 7 2018 at UTC 07:00  -- Presenter Abby Abraham, OmniComm Systems

              Wed, Nov 17 2018 at UTC 16:00 – Presenter Ken Light, OmniComm Systems

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