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Full Description
Data management is an integral part of the clinical trial process; it not only assures data quality but also ensures the integrity, validity, and consequently the success of the clinical trial. The use of electronic data capture (EDC) has recently received much attention. From technology selection to workflow implementations to warehousing of clinical trial data from multiple sources, this handbook provides the first definitive resource on the factors that are predictive of successful global EDC implementations. Written by experts in the field, the book discusses uses of EDC in clinical data management and details complementary technologies in an overall e-clinical strategy.
Contents
BUSINESS, REGULATORY, AND RISK MANAGEMENT CONSIDERATIONS WITH EDC Value Proposition of EDC: Savings and Efficiencies to Extend Value across Development Programs, Shein-Chung Chow Regulatory Requirement and Key Quality Assurance Factors Associated with EDC, Sudhir Achar Traditional Paper Methods versus EDC, Thomas Bart How EDC Alters Traditional CRO Contracts Anne Wiles Business Model for Global EDC Deployment, Johan Proeve TECHNOLOGY FACTORS of Delivery, Junfang Li System Validation and Part II Compliance, Denny Clziang, Janssen, and Robert Musterer Critical Factors to the Global EDC Implementation, Achim Reeb Hosting EDC Considerations, Phaseforward rep Internal versus Outsourced Hosting of Worldwide EDC Implementations, David Cambra GCP Guidelines for EDC Applications, Jeffrey A. Green Homegrown EDC versus Outsourced EDC, Sylva Collins and Johan Proeve DATA MANAGEMENT WITH EDC IT and Hosting Perspectives, Data Repository Strategies and the Importance of Integration with Diverse Applications: Regulatory and Efficiency Considerations, Joe Carter The Life Sciences Network: A Centralized Offering of a Group of Technologies That Are Necessary for a Full e-Clinical Initiative, Importance for the Future of Being Able to Unify Data, DATATRAK Development Team CDMS versus No CDMS, Stephen Ruberg, Lilly and/or Rickie Stevens, and/or Ron Fitzmartin Strategy for Future Data Management: Design, Structure, and Function, Adrian Hsing and Robert Halstead Leadership Role of CDISC and Standardization Initiatives in Future Clinical Trials, Studies of Efficient and Inefficient Use of EDC in Clinical Trials, Wolfgang Summa and Marc Shlaes Future Role of Technology Transfer in Empowering Clinical Trial Sponsors and CROs, Adrian Hsing COMPLEMENTARY TECHNOLOGIES IN AN OVERALL e-CLINICAL STRATEGY Clinical Trial Site Management and Tracking Capabilities, IVRS Technology: Now and Future Developments, Jonathan Engler, and Jim Chu Role of Patient Diary Applications in Clinical Research, Doug Engfer Use of Technology in Post-Approval Regulatory Surveillance and Patient Registry Studies, Analysis Data Set/Submission Data Set Standard, Aileen Yam CDISC Controlled Terminology, Bron W. Kisler
