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Practical Guide to Clinical Data Management

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Release : 2011-10-26
Genre : Computers
Kind : eBook
Book Rating : 319/5 ( reviews)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha. This book was released on 2011-10-26. Available in PDF, EPUB and Kindle. Book excerpt: 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,

Clinical Data Management

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Release : 2000-02-03
Genre : Medical
Kind : eBook
Book Rating : 293/5 ( reviews)

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Book Synopsis Clinical Data Management by : Richard K. Rondel

Download or read book Clinical Data Management written by Richard K. Rondel. This book was released on 2000-02-03. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Guide to Clinical Data Management

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Author :
Release : 1999-01-31
Genre : Medical
Kind : eBook
Book Rating : 438/5 ( reviews)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha. This book was released on 1999-01-31. Available in PDF, EPUB and Kindle. Book excerpt: 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 clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

Medical Data Management

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Author :
Release : 2003-01-14
Genre : Computers
Kind : eBook
Book Rating : 591/5 ( reviews)

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Book Synopsis Medical Data Management by : Florian Leiner

Download or read book Medical Data Management written by Florian Leiner. This book was released on 2003-01-14. Available in PDF, EPUB and Kindle. Book excerpt: 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 medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

The Fundamentals of Clinical Data Management

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Release : 2015-08-08
Genre : Clinical trials
Kind : eBook
Book Rating : 576/5 ( reviews)

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Book Synopsis The Fundamentals of Clinical Data Management by : S. Fernandez

Download or read book The Fundamentals of Clinical Data Management written by S. Fernandez. This book was released on 2015-08-08. Available in PDF, EPUB and Kindle. Book excerpt: "The Fundamentals of Clinical Data Management" is a manual for Sponsors, CROs, Investigators, Clinical Trial Monitors and Managers and Clinical Research Professionals to learn the basic concepts of Clinical Data Management. This book will focus on the topic which includes: Clinical Information Flow, Roles and Responsibilities of CDM Personnel, Guidelines Associated with CDM, Data Management Plan, CRF Designing, Data Collection, Cleaning and Data Validation, Study setup and Database Designing, Laboratory Data and Adverse Event Data Management, Report Creation and Data Closure, Data Archiving, Privacy and Security etc.

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