Practical Guide To Clinical Data Management Third Edition
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Author | : Susanne Prokscha |
Publisher | : CRC Press |
Total Pages | : 296 |
Release | : 2011-10-26 |
Genre | : Computers |
ISBN | : 1439848319 |
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,
Author | : Florian Leiner |
Publisher | : Springer Science & Business Media |
Total Pages | : 230 |
Release | : 2003-01-14 |
Genre | : Computers |
ISBN | : 9780387951591 |
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.
Author | : JoAnn Pfeiffer |
Publisher | : CRC Press |
Total Pages | : 292 |
Release | : 2017-05-18 |
Genre | : Mathematics |
ISBN | : 1315299771 |
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Author | : Graham Ogg |
Publisher | : CRC Press |
Total Pages | : 229 |
Release | : 2005-11-01 |
Genre | : Medical |
ISBN | : 104006163X |
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
Author | : Susanne Prokscha |
Publisher | : CRC Press |
Total Pages | : 298 |
Release | : 2011-10-26 |
Genre | : Computers |
ISBN | : 1439848297 |
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.
Author | : Pamela E. Macintyre |
Publisher | : CRC Press |
Total Pages | : 282 |
Release | : 2014-12-04 |
Genre | : Health & Fitness |
ISBN | : 1482233509 |
Highly Commended, BMA Medical Book Awards 2015Comprehensive acute pain management no longer means only caring for patients with pain resulting from postoperative and trauma-related causes-it now includes managing patients with acute pain arising from a wide variety of conditions. Acute Pain Management: A Practical Guide provides health professional
Author | : Robert E. Hoyt |
Publisher | : Lulu.com |
Total Pages | : 349 |
Release | : 2008 |
Genre | : Medical informatics |
ISBN | : 9781435753563 |
Medical informatics is a new field that combines information technology and clinical medicine to improve medical care, medical education and medical research. With over 1,000 references, this extensively updated second edition will serve as a practical guide for understanding the field of Medical Informatics. Topics covered include: Overview of Medical Informatics, Electronic Health Records, Interoperability, Patient Informatics, Online Medical Resources, Search Engines, Mobile Technology, Evidence Based Medicine, Clinical Practice Guidelines, Pay for Performance, Disease Management and Disease Registries, Patient Safety, Electronic Prescribing, Telemedicine, Picture Archiving and Communication Systems, Bioinformatics, Public Health Informatics, E-research, and Emerging Trends
Author | : Duolao Wang |
Publisher | : Remedica |
Total Pages | : 497 |
Release | : 2006 |
Genre | : Medical |
ISBN | : 1901346722 |
This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Author | : Fay A. Rozovsky |
Publisher | : Jossey-Bass |
Total Pages | : 0 |
Release | : 2003-06-10 |
Genre | : Medical |
ISBN | : 9780787965709 |
This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Author | : Susanne Prokscha |
Publisher | : CRC Press |
Total Pages | : 266 |
Release | : 2024-07-03 |
Genre | : Medical |
ISBN | : 1040042112 |
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.