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More About This Textbook
Overview
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.
It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
The book contains black-and-white illustrations.
Editorial Reviews
From the Publisher
"The key to enduring research is data quality and data quality depends upon data management. How fortunate then that the start of the New Millennium sees the publication of the second edition of 'Clinical Data Management'. ... Admirably concise and authoritatively penned, it provides an excellent introduction to a subject at the heart of pharmaceutical R&D.", Dr Hugh Boardman, Partner in Boardman Clarke, Pharmaceutical Physician#Doody's Review Service
Reviewer: Howard M. Kravitz, DO, MPH (Rush University Medical Center)Description: This updated and expanded edition covers a wide range of topics that comprise the discipline of clinical data management (CDM). Authors from both sides of the Atlantic enlighten readers about the diverse and complex aspects of efficient clinical data management procedures that apply particularly to the pharmaceutical industry.
Purpose: Developments in CDM and in the activities of drug regulatory authorities in the U.S. and abroad since the first edition of this book was published in 1993 were the impetus for publishing this new edition. While it is "difficult at best" to clearly and cleanly define CDM, the editors have compiled a text that provides "one of the very few in-depth resources for CDM professionals" (Foreword). Coverage includes historical background and information on CDM procedures pertinent to satisfying corporate objectives and regulatory agency audits.
Audience: To author the book's 17 chapters, the editors assembled an international group of contributors who are considered experienced and knowledgeable regarding their topics. The targeted audience is persons in the field of CDM within the pharmaceutical or associated industries and biomedical professionals engaged in clinical research.
Features: The central theme of this text is to demonstrate the impact of CDM practices on regulatory, technical, and operational areas of clinical development. Many of the described changes in the field of CDM are related to globalization in our electronic era. "Time is money" is another message. Practice lags behind technology; despite electronic data capture capabilities, 95 percent of clinical trials still use paper case report forms (p. 328). Tables and figures highlight textual material, which generally is well organized. Although better written than a technical manual, which it is not, I was disoriented by the use of undefined terminology, beginning with the aforementioned difficulty defining CDM itself, and distracted by the excessive use of acronyms, sometimes defined only in the index.
Assessment: This new edition provides much valuable information directed toward the CDM professional. Its rather steep price is likely to deter other potential readers, such as researchers with primary interests in data management procedures, who are less concerned with the corporate and regulatory aspects of data management.
3 Stars from Doody
Product Details
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Table of Contents
Chapter Review (S. Cummings).
The International Conference on Harmonisation and its Impact (B. Smith & L. Heywood).
Case Report Form Design (M. Avey).
Data Capture (E. Waterfield).
Planning and Implementation (C. Thomas).
Data Validation (P. Patel).
Quality Assurance and Clinical Data Management (H. Campbell & J. Sweatman).
Performance Measures (J. Wood).
Data Presentation (M. Mehra).
Coding of Data-MedDRA and other Medical Terminologies (E. Brown & L. Wood).
Database Design Issues for Central Laboratories (T. Tollenaere).
Computer Systems (L. Palma).
Systems Software Validation Issues-Clinical Trials Database Environment (S. Hutson).
Re-engineerng the Clinical Data Management Process (S. Arlington, et al.).
Working with Contract Research Organizations (K. Buchholz).
Data Management in Epidemiology and Pharmacoeconomics (M. Ryan & A. Pleil).
Future Revisited (R. Lane).
Index.