Practical Guide to Clinical Data Management Third Edition

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 ...

Practical Guide to Clinical Data Management  Third Edition

Practical Guide to Clinical Data Management Third Edition

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.

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Practical Guide to Clinical Data Management, Third Edition
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Pages: 296
Authors: Susanne Prokscha
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Type: BOOK - Published: 2011-10-26 - Publisher: CRC Press

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
Medical Data Management
Language: en
Pages: 204
Authors: Florian Leiner, Wilhelm Gaus, Reinhold Haux, Petra Knaup-Gregori
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Type: BOOK - Published: 2006-04-18 - Publisher: Springer Science & Business Media

Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in
Practical Guide to Clinical Data Management
Language: en
Pages: 256
Authors: Susanne Prokscha
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Type: BOOK - Published: 2006-08-01 - Publisher: CRC Press

The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task
Introduction to Health Research Methods: A Practical Guide
Language: en
Pages: 380
Authors: Kathryn H. Jacobsen
Categories: Medical
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Designed to empower new investigators to conduct their own original research projects, the third edition of Introduction to Health Research Methods: A Practical Guide leads the reader step-by-step guide in performing quantitative and qualitative research in medicine, public health, and other clinical and population health fields. Organized in five sections,
Pharmaceutical Statistics Using SAS
Language: en
Pages: 464
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Categories: Computers
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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.

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