Reports, Presentations, Articles and Publications

The information presented in these documents is provided as an aid to understanding the environment for electronic clinical research and draws upon the information and understanding of the eClinical Forum. The content is unconfirmed and readers should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.


The Terminology Used Within the eHealth Environment
Your Guide to eHealth Acronyms, Initiatives and Terminology 

Available: 

May 2006

Price:

  Free

Download Paper 450k zip

Work being undertaken by the eClinical Forum has exposed the group to a wide vocabulary of acronyms and terminology related to the various eHealth initiatives ongoing around the world. The purpose of this document is to consolidate definitions of terms and access to further information as an aid to other groups and individuals with an interest in eHealth and the potential future environment for the conduct of electronic clinical trials. This document is a ‘work in progress’ and is intended to be adapted and to grow as we gain more information and as the environment changes. We welcome any contributions to the content to ensure that it is accurate and complete..

The Future of Electronic Clinical Trials  

Available: 

March 2006

Price:

  Free

Download Paper 450k zip

A document presenting information on the current status and changing environment for the conduct of electronic Clinical Trials. The document presents a possible future scenario of a single electronic source and describes the risks, benefits and business impact.

US PhRMA's EDC Position Paper Revision 1 

Available: 

May 2005

Price:

  Free

Download Paper 450k zip

The latest revision of a document prepared by the Clinical Trial Electronic Data Capture Task Group from the US PhRMA Biostatistics and Data Management Technical Group. The purpose of this position paper is to recommend processes and standards that advance the use of electronic capture of clinical trial data and inclusion of that data in regulatory submissions, with the intent of reducing clinical data error, increasing productivity of communication between sponsor and investigator, and reducing time to regulatory submission.

eCF Presentation to EMEA GCP Inspectors on EDC  

Available: 

May 2003

Price:

  Free

Download Paper 400k zip

This presentation contains copies of materials prepared by members of the eClinical Forum for the GCP Inspectors’ Training Seminar on 22nd October 2003. The presentation covers Practical Approaches to Achieving Regulatory Compliance in the Implementation of EDC.

 

eSource Position Paper  

Available: 

May 2003

Price:

  Free

Download Paper 200k zip

Discussion document of the advantages and implications of eSource.

 

Regulatory Environment for EDC

Available: 

May 2003

Price:

  Free

Report Download Paper 300k zip

Presentation Download Paper 400k zip

Overview of regulatory environment for EDC.

 

Summary of Regulatory Sub Group Discussions 

Available: 

Dec 2001

Price:

  Free

Download Paper 200k pdf

Outputs from discussion by the Regulatory subgroup.

 

Cost:Benefit of EDC  

Available: 

Q3 2001

Price:

  Free

Download Paper 400k pdf

Overview of cost:benefit issues.

Back to Top

Copyright © 2008 eClinical Forum.
Last Updated: June 05, 2008 .