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Practical Guide to Clinical Data Management de Susanne Prokscha
Descripción - Reseña del editor The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers. Biografía del autor Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.
Detalles del Libro
- Name: Practical Guide to Clinical Data Management
- Autor: Susanne Prokscha
- Categoria: Libros universitarios y de estudios superiores,Medicina y ciencias de la salud,Administración y política
- Tamaño del archivo: 7 MB
- Tipos de archivo: PDF Document
- Descargada: 196 times
- Idioma: Español
- Archivos de estado: AVAILABLE
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Practical Guide to Clinical Data Management (English ~ As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management.
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[PDF] Practical Guide To Clinical Data Management Third ~ And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance.
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Practical Guide to CLINICAL DATA MANAGEMENT ~ Practical Guide to CLINICAL DATA MANAGEMENT Susanne Prokscha (g) CRC Press Taylor Francis Croup Londo Yornk CRC Press is an imprint of the Taylor Francis Croup, a n buslness . Contents Preface xv Introduction xvii i Startup 1 The Data Management Plan 3 History .
Practical Guide to Clinical Data Management (3rd ed.) ~ Practical Guide to Clinical Data Management (3rd ed.) by Susanne Prokscha. <P>The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment.
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A practical guide to clinical data management - 新药研发 - 小木虫 ~ A practical guide to clinical data management. . reflected the state of clinical data management and the industry at that time. A new Food and Drug Administration (FDA) regulation, 21 CFR 11, “Electronic Records; Electronic Signatures,” had just come into effect at the time
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Practical guide to clinical data management (Book, 2007 ~ Examining the role of data management in clinical trials, this work provides an introduction to the key process elements of clinical data management. It incorporates the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures.
Practical Guide to Clinical Data Management - Susanne ~ Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in .
Practical Guide to Clinical Data Management by Susanne ~ Clinical data management (CDM) has gone from predominantly relying on the collection of data on paper forms to using electronic data capture (EDC). Today, the assumption is that a trial will be conducted using EDC and that extenuating circumstances might lead to it being conducted using paper. This third edition emphasizes the EDC process.
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Practical guide to clinical data management (Book, 2012 ~ ISBN: 9781439848296 1439848297: OCLC Number: 606777770: Notes: Includes index. Description: xxi, 274 pages ; 25 cm: Contents: Introduction --The data management plan --CRF design considerations --Database design considerations --Edit checks --Preparing to receive data --Receiving data on paper --Overseeing data collection --Cleaning data --Managing lab data --Non-CRF data --Collecting adverse .
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Practical Guide To Clinical Data Management, 3Rd Ed ~ Practical Guide To Clinical Data Management, 3Rd Ed. Hardcover – January 1, 2016 by PROKSCHA (Author) See all formats and editions Hide other formats and editions. Price New from Used from Hardcover, January 1, 2016 "Please retry" — — — Hardcover — .
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