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Clinical Data Management,
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.
by Richard K. Rondel
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Practical Guide to Clinical Data Management, Second Edition,
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 to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures Practices for both electronic data capture (EDC)-based and paper-based studies A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.
by Susanne Prokscha
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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.
by Susanne Prokscha
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Clinical Analytics and Data Management for the DNP,
Strong data management knowledge and skills are a requirement for every DNP graduate. This unique text focuses on fostering the rigorous, meticulous data management skills that can improve care experience, health outcomes, and cost-savings worldwide. It provides a knowledge base, describes the regulatory and ethical context, outlines a process to guide evaluation, presents a compendium of resources, and includes examples of evaluation of translation effects. It takes the DNP student step-by-step through the complete process of data management including planning, data collection, data governance and cleansing, analysis, and data presentation. Moreover, the text continues the process of establishing a sturdy clinical data management (CDM) skill base by presenting techniques for ongoing project monitoring after analysis and evaluation are concluded.
by Martha Sylvia PhD, MBA, RN
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Handbook of Research on Information Technology Management and Clinical Data Administration in Healthcare,
"This book presents theoretical and empirical research on the value of information technology in healthcare"--Provided by publisher.
by Dwivedi, Ashish N.
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Medical Data Management,A Practical Guide
Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. This book addresses important classification systems such as the ICD-9 and -10 and instructs the reader in the process of patient care in a highly specialized healthcare system, with attention to maintaining medical quality and cost-effectiveness in establishing an integrated and easily manageable system. It speaks to healthcare professionals needing to learn the principles and implementation of integrated, systematic data management systems.
by Florian Leiner
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Management of Data in Clinical Trials,
by Eleanor McFadden
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Clinical Data Management,Patient-Reported Outcome, Electronic Common Technical Document, Clinical Data Interchange Standards Consortium
by General Books LLC
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Data Management and Clinical Trials,EORTC Study Group on Data Management
There are, at present, some 2000 clinical trials in progress all over the world. For various reasons, however, a good portion of them will not have any impact on oncological practice, mainly because they were poorly designed, inappropriately conducted, improperly analysed, of poor quality or repetitive. There is obviously an acute need for better education in clinical trials among clinicians, so that they will concentate only on significant trials properly conducted, and recruiting a large number of patients. This book presents a sound evaluation of the problems connected with the conduct of clinical trials, with a special emphasis on the need for a strict interaction between clinicians, data managers and statisticians. Most of the crucial problems related to data management and clinical trials have been reviewed, and the reader is furnished with an objective picture of a subject which although hostile to many doctors should become familiar to all clinicians who have at heart the duty and desire to combine the progress of science with the safeguard of the cancer patient.
by Nicole Rotmensz
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Design and Analysis of Clinical Trials,Concepts and Methodologies
Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
by Shein-Chung Chow
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Principles and Practice of Clinical Research,
The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research Delves into data management and addresses how to collect data and use it for discovery Contains valuable, up-to-date information on how to obtain funding from the federal government
by John I. Gallin
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Medical Informatics Europe '99,
This volume seeks to reflect the state of the art on medical informatics. It presents ideas that will guide the process of medical informatics. Topics in the book include: information systems in health care and medicine; telemedicine and telematics; security; biomedical processing, data mining and knowledge discovery; training and education; Internet/intranet; resources management; intelligent medical systems; health guidelines and protocols; electronic patient encounter, card technology, electronic data interchange; terminology; nursing informatics.
by Peter Kokol
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Statistical Methods for Clinical Trials,
"Summarizes graphical analysis, analysis of variance, meta-analysis, and design of comparable treatment groups. Streamlines the analytical techniques for continuous, categorical, longitudinal, and survival data-focusing on generalized linear models, GEEs, and mixed linear models, -ahd highlihgts p-value, and more."
by Mark X. Norleans
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Designing Clinical Research,
This third edition sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology and offers an updated syllabus for conducting a clinical research workshop.
by Stephen B. Hulley
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Analysis of Clinical Trials Using SAS,A Practical Guide
In Analysis of Clinical Trials Using SAS: A Practical Guide, Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, and Walter Offen bridge the gap between modern statistical methodology and real-world clinical trial applications. Step-by-step instructions illustrated with examples from actual trials and case studies serve to define a statistical method and its relevance in a clinical trials setting and to illustrate how to implement the method rapidly and efficiently using the power of SAS software. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials, including analysis of stratified data, incomplete data, multiple inferences, issues arising in safety and efficacy monitoring, and reference intervals for extreme safety and diagnostic measurements. Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience compiled in this book. Numerous ready-to-use SAS macros and example code are included. This book is part of the SAS Press program.
by Alex Dmitrienko
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