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    Validating electronic source data clinical trials

    Sadly, we continue to see residual, frequent emphasis on checking these transcription activities when electronic systems can easily eliminate this highly inefficient process.

    Doing the math, moving to electronic systems can provide a dramatic return on investment by 1) reducing labor costs at the clinical research sites and sponsoring companies, 2) reducing travel costs, and 3) providing improvements in data quality.

    One area of enhanced clinical trial conduct is believed to be available by moving from paper-based source documents to electronic source documents, that is, eliminating paper from clinical data capture, and collecting the information initially in a computer system.

    An important concern in moving to electronic source data is the validation of such data.

    Synthesis Lectures on the Semantic Web: Theory and Technology, 1:1, 1-136. DOI: 10.2200/S00334ED1V01Y201102WBE001 ISBN: 9781608454303 (paperback) ISBN: 9781608454310 (ebook) Copyright © 2011 by Morgan & Claypool. The World Wide Web has enabled the creation of a global information space comprising linked documents.

    As the Web becomes ever more enmeshed with our daily lives, there is a growing desire for direct access to raw data not currently available on the Web or bound up in hypertext documents.

    In 2008, the Clinical Trial Transformational Initiative (CTTI), a public-private partnership with the FDA, and Duke University, was established to identify practices that, through broad adoption, will increase the quality and efficiency of clinical trials.

    This paper summarizes the history of clinical data capture through paper and electronic advancements to date and identifies three reasons for the slow movement to more electronic source data.

    The paper then illustrates two methods for the validation of electronic source data.

    Guidance ICH E6 and the regulatory authorities that have adopted it, refer to source documents (i.e., primary health records, in the sections on investigators, sponsors, trial protocols, and essential documents).

    According to the E6 guidance, source documents must be kept in good order and investigators must make source documents available to the sponsor and monitors working on behalf of the sponsor.

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