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Site Survey 2016

The eClinical Forum is a non-commercial group working to improve the use of technology in clinical research. One of the objectives of the eClinical Forum is to increase the involvement of site staff in defining current and future requirements of technology systems and processes used in clinical research.

The Site Survey 2016 survey is open to all site staff involved in clinical trials. The information collected will be used to help us continue to improve the way clinical trial systems and processes are provided and used. You can read about the results of previous site surveys in 2001 and 2009 here.

By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes.


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Latest eClinical Forum News

NEWSWORTHY...
NL initiative to assess electronic health record systems using eCF eSRA tool

The Dutch Clinical Trial Foundation (DCTF) has endorsed an EHR working group committed to the implementation of one uniform tool for the validation of electronic health record (EHR) systems used at clinical research sites within the Netherlands. The group consists of representatives from several pharmaceutical companies, CROs and hospitals, and is chaired by Martijn Griep, Johnson & Johnson Regional QC Manager, coordinated by Dana De Beuckelaer-Dournez from the University of Antwerp.

After considerable research and discussion with national stakeholders, the working group has chosen to use the eSRA (eSource-Readiness Assessment) program...

 read more ...

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.

 

 

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