Practical Guide to Clinical Data Management, Third Edition (Anglais) Relié – 18 novembre 2011
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Description du produit
Présentation de l'éditeur
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.
Biographie de l'auteur
Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.
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Commentaires client les plus utiles sur Amazon.com
As a practicing Clinical Data Manager seeking to complete a first Data Management Plan template, I found this text invaluable. Before purchasing I had studied SCDM's Good Clinical Data Management Practices (GCDMP) and had completed SCDM's DMP course. Additionally I had reviewed all of SCDM's online newsletters. All of these resources are useful and valuable; the book reviewed here does an excellent job of tying everything together and extending the other useful works. Susanne Prokscha is an actively contributing member of SCDM and her book is widely referenced by SCDM.
If I had to rely on a single resource, Practical Guide to Clinical Data Management, Third Edition would be it. This is the book I wish I had when I first became Data Manager a few years ago. As a Programmer / Analyst with 30 years experience I find her treatment of Database Design Considerations (and other mentions of databases issues) accurate yet understandable to non-computer types.
Rather than my trying to discuss further details here, let me just say that if you’re looking for a good overall source of information for clinical data management this is it.
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