Resource Center: Electronic Data Capture (EDC)

EDC Resources

• Articles, Presentations, and Webcasts
• Vendors
• CDISC (Clinical Data Interchange Standards Consortium)
• FDA Guidance

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Articles, Presentations, and Webcasts Articles Below is a representative sample of recent articles that cover topics ranging from defining and understanding EDC to specific processes and technologies to metrics and ROI measures.   Search, filter and sort all articles. Periodicals The following periodicals frequently contain articles about EDC.   • Bio-IT World   • Applied Clinical Trials   • PharmaVOICE The following links lead to compilations of EDC articles from Bio-IT World and Applied Clinical Trials.   • Bio-IT World Briefing On: Electronic Data Capture "This compilation of Bio-IT World coverage of EDC since 2002 combines a dozen print and e-newsletter stories by senior editor Mark D. Uehling." [Requires registration with Bio-IT World for free download.]   • Applied Clinical Trials: Electronic data capture

Featured Article Former and current clients discuss the state of the art and the future of EDC. It's Standards Time - Pharma does EDC in clinical trials, but is anyone doing it right? "Technology is primarily what's driving improved operational efficiency in clinical development today, ... And EDC is probably the one technology that more companies are embracing for the first time than any other tool." Opinion Polls & Market Research   Current EDC news     More Electronic Data Capture news at Yahoo! News.      More news Quick Reference The sites below provide definition for pharmaceutical, technology, and project management terms and phrases. • ClinicalTrials.gov - Glossary of Clinical Trials Terms • Hyperdictionary Medical Dictionary • Medical Dictionary Search Engine • Tufts - Glossary of Terms • Wikipedia • CDISC Clinical Research Glossary, Version 5.0 • Acronyms, Abbreviations, and Initials, Version 5.0

Case Study
Download our case study on Phase I EDC. Then, let us know what you think. Is EDC worthwhile for Phase I studies? Contact us.

Presentations Phoenix Data Systems Releases 2006 SCDM Fall Conference EDC Adoption: Considerations for Sites - Designing Systems and Processes for Electronic Data Capture Webcasts The links below lead to archived webcasts sponsored by Phase Forward and Applied Clinical Trials. Flexibility Leads to Success: Seamless Paper Data Entry and EDC Integration for Clinical Trials Phase Forward Archived Events The Convergence of Data: Healthcare and Life Sciences DIA periodically offers EDC related webinars - check here using the keyword "EDC" DIA - Find An Educational Offering

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Vendors Below is a list of vendors that offer EDC tools and technologies. Almac Clinical Technologies ClinPhone (DataLabs) DATATRAK DSG eResearchTechnology eTrials Fast Track Systems Formedix LifeTree Technology Medidata Solutions Nextrials Octagon Research Solutions Omnicomm Systems OpenClinica Oracle Phase Forward Phoenix Data Systems TrialStat VISTA

CDISC (Clinical Data Interchange Standards Consortium)
Visual Edge Consulting & Software is a member of CDISC, and actively participates in the Operational Data Model (ODM) Team where we have helped to shape CDISC standards.

“CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.”
• http://www.cdisc.org

Phase Forward's "Undertanding CDISC Basics" white paper provides an overview of the various CDISC standards and their usage. Note that access to the paper requires registration at Phase Forward's web site.

eClinical Trials: Planning and Implementation
Rebecca Daniels Kush, PhD, Paul Bleicher, MD, Stephen Raymond, PhD, Wayne Kubich, Ronald Marks, Barbara Tardiff

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FDA Guidance
Following is a small subset of frequently referenced FDA guidance.

Computerized Systems Used in Clinical Trials - April, 1999
This document provides guidance for development...
• http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf

Draft Guidance - Computerized Systems Used in Clinical Trials - September, 2004
This document provides guidance for development...
• http://www.fda.gov/cder/guidance/6032dft.pdf

Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
• http://www.fda.gov/ora/compliance_ref/part11/

Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
• http://www.fda.gov/ora/inspect_ref/igs/gloss.html

A list of all the FDA’s current guidance documents is available here.
• http://www.fda.gov/cder/guidance/ 

• International Conference on Harmonisation (ICH)

• A GCP Primer:Understanding The Basic Application Of Good Clinical Practice In The Regulated Environment For The Quality Professional

• National Cancer Institute - Clinical Trials Management Resource