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eClinical Forum Events

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Latest eClinical Forum News

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.


·         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.

·         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)

·         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.



eSRA (eSource Readiness Assessment) Released!

The eClinical Forum has produced an easy online tool for investigative sites to use to assess their healthcare system to determine if they are suitable to originate data that could become part of a clinical trial. eSRA (eSource Readiness Assessment) produces a report that sites can provide to all of their sponsors, thus avoiding the burden of completing different forms for each sponsor. The eSRA template is based on EMA and FDA regulations and guidances and has been reviewed and piloted by many sponsors, CROs, EHRvendors, and Investigative sites. The completed assessment is suitable to be included in eTMF documentation and provided to regulatory authorities. The tool is available FREE to all -- please check it out at: www.eclinicalnetwork.org


Want to know more?... Watch short videos... About eSRA      Training Webinar

 read more ...

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