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. Available: May 2006 Price: Free
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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.. Available: March 2006 Price: Free
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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. Available: May 2005 Price: Free
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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. Available: May 2003 Price: Free
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Paper 400k zip
The Terminology Used Within the
eHealth Environment
Your Guide to eHealth Acronyms, Initiatives and Terminology
The Future of Electronic Clinical Trials
US PhRMA's EDC Position
Paper Revision 1
eCF Presentation to
EMEA GCP Inspectors on EDC
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: |
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Discussion document of the advantages and implications of eSource.
| Regulatory Environment for EDC |
Available: |
May 2003 |
Price: |
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Overview of regulatory environment for EDC.
| Summary of Regulatory Sub Group Discussions |
Available: |
Dec 2001 |
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Outputs from discussion by the Regulatory subgroup.
| Cost:Benefit of EDC |
Available: |
Q3 2001 |
Price: |
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Overview of cost:benefit issues.