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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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eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
30
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
1
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
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