Clinical Data Management
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Clinical Data Management
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Author : Richard K. Rondel
language : en
Publisher: John Wiley & Sons
Release Date : 2000-02-03
Clinical Data Management written by Richard K. Rondel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-02-03 with Medical categories.
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 : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-26 with Computers categories.
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 Fundamentals Of Clinical Data Management
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Author : S. Fernandez
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2015-08-08
The Fundamentals Of Clinical Data Management written by S. Fernandez and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-08 with Clinical trials categories.
"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.
Practical Guide To Clinical Data Management Third Edition
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
Practical Guide To Clinical Data Management Third Edition written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-26 with Computers categories.
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.
Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2006-08-01
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-08-01 with Medical categories.
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 in the late 1970s and early 1980s t
Medical Data Management
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Author : Florian Leiner
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-04-18
Medical Data Management written by Florian Leiner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-04-18 with Medical categories.
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.
A Guide To Gcp For Clinical Data Management
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Author : MARK. ELSLEY
language : en
Publisher:
Release Date : 2017
A Guide To Gcp For Clinical Data Management written by MARK. ELSLEY and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
Clinical Analytics And Data Management For The Dnp Second Edition
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Author : Martha L. Sylvia, PhD, MBA, RN
language : en
Publisher: Springer Publishing Company
Release Date : 2018-03-28
Clinical Analytics And Data Management For The Dnp Second Edition written by Martha L. Sylvia, PhD, MBA, RN and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
Praise for the First Edition: “DNP students may struggle with data management, since their projects are not research, but quality improvement, and this book covers the subject well. I recommend it for DNP students for use during their capstone projects." Score: 98, 5 Stars --Doody's Medical Reviews This is the only text to deliver the strong data management knowledge and skills that are required competencies for all DNP students. It enables readers to design data tracking and clinical analytics in order to rigorously evaluate clinical innovations/programs for improving clinical outcomes, and to document and analyze change. The second edition is greatly expanded and updated to address major changes in our health care environment. Incorporating faculty and student input, it now includes modalities such as SPSS, Excel, and Tableau to address diverse data management tasks. Eleven new chapters cover the use of big data analytics, ongoing progress towards value-based payment, the ACA and its future, shifting of risk and accountability to hospitals and clinicians, advancement of nursing quality indicators, and new requirements for Magnet certification. The text takes the DNP student step by step through the complete process of data management from planning to presentation, and encompasses the scope of skills required for students to apply relevant analytics to systematically and confidently tackle the clinical interventions data obtained as part of the DNP student project. Of particular value is a progressive case study illustrating multiple techniques and methods throughout the chapters. Sample data sets and exercises, along with objectives, references, and examples in each chapter, reinforce information. Key Features: Provides extensive content for rigorously evaluating DNP innovations/projects Takes DNP students through the complete process of data management from planning through presentation Includes a progressive case study illustrating multiple techniques and methods Offers very specific examples of application and utility of techniques Delivers sample data sets, exercises, PowerPoint slides and more, compiled in Supplemental Materials and an Instructor Manual
Fundamentals Of Clinical Data Science
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Author : Pieter Kubben
language : en
Publisher: Springer
Release Date : 2018-12-21
Fundamentals Of Clinical Data Science written by Pieter Kubben and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-21 with Medical categories.
This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Clinical Data Management
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Author : Richard Rondel
language : en
Publisher:
Release Date : 2000
Clinical Data Management written by Richard Rondel and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with categories.
This volume covers all aspects of clinical data management, including such specialized fields as clinical trial monitoring, the audit process and regulatory requirements. The text should benefit those involved in pharmaceutical, biomedical and related research.