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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Considerations for the
Implementation of ePRO in Clinical Studies
The aim of this handbook is to provide guidance on implementing technology solutions to handle electronic patient reported outcomes (ePRO). ePRO is an emerging field and this handbook brings together knowledge from ePRO experiences but is also be structured such that the document can grow and change as this knowledge base grows. The initial release of this handbook describes ePRO in general and provides a roadmap for those wanting to get started with this technology. We welcome any contributions to the content to ensure that it is accurate and complete..
| The Future Vision of EHRs as eSource for Clinical Research (Release 1, 14-Sep-06) |
Available: |
Sep 2006 |
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The Terminology Used Within the
eHealth Environment Your Guide to eHealth Acronyms, Initiatives and Terminology |
Available: |
May 2006 |
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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 |
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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 |
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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 |
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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 |
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Discussion document of the advantages and implications of eSource.
| Regulatory Environment for EDC |
Available: |
May 2003 |
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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 |
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Overview of cost:benefit issues.