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eCF Releases Key Documents and Tools

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  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 12707
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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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Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

May 11-13 2020:  New Jersey, USA hosted by Diligent Pharma

But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

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Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

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But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

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