Download or read book Practical Guide to Clinical Data Management Third Edition written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 298 pages. 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, 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.
Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2006-08-01 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Medical Data Management written by Florian Leiner and published by Springer Science & Business Media. This book was released on 2006-04-18 with total page 208 pages. 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.
Download or read book A Practical Guide to Quality Management in Clinical Trial Research written by Graham Ogg and published by CRC Press. This book was released on 2005-11-01 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book A Textbook of Clinical Ophthalmology written by R. Pitts Crick and published by World Scientific. This book was released on 2003 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: The material in this edition of A d104book of Clinical Ophthalmology has been thoroughly revised and expanded to include the latest research and practice. Containing 357 illustrations throughout the text, the book is not only a reasoned practical guide to the study of ophthalmology, but it embraces the ocular aspects of general diseases world-wide and basic methods of investigation and treatment where applicable.This book has references by page and illustration number, resulting from collaboration with the authors of Colour Atlas of Ophthalmology; the two books contain all together an outstanding 579 illustrations (343 in colour), including 16 stereo plates. Another companion book is The Ophthalmology Examinations Review, which aims at the most effective presentation of knowledge for examination purposes. Together these three compact and inexpensive books provide an excellent study basis for ophthalmologists in training, while supplementing their learning of clinical work and surgical technique with the essential study of recent research papers and review monographs.
Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2024-07-03 with total page 266 pages. 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 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.
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Informatics written by Robert E. Hoyt and published by Lulu.com. This book was released on 2008 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Fundamentals of Clinical Data Management written by S. Fernandez and published by Createspace Independent Publishing Platform. This book was released on 2015-08-08 with total page 0 pages. 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.
Download or read book Management of Data in Clinical Trials written by Eleanor McFadden and published by John Wiley & Sons. This book was released on 2007-12-14 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.
Download or read book The Duty for Sponor Oversight in Clinical Trials written by Doris Breiner and published by BoD – Books on Demand. This book was released on 2022-12-22 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis released in April 2019. The next edition will focus on the Clinical Data Review which includes all aspects to be considered, for example, the outcome of the overall monitoring oversight activities. Furthermore, to describe and show examples of a standardized score assignment to ensure a unique process of the assessment.
Download or read book A Practical Approach to Analyzing Healthcare Data written by Susan White and published by . This book was released on 2016 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A Practical Approach to Analyzing Healthcare Data, Third Edition, offers guidance to healthcare professionals and health information management (HIM) students on how to best analyze, categorize, and manage the data that they encounter in an industry becoming ever more dependent on these tasks. With expanded and reorganized content on statistical analysis techniques, and new content on value-based purchasing (VBP) analytics and risk adjustment, this text applies broader principles of data evaluation specifically to the field of HIM. Updated and augmented online resources give professionals and students access to actual data sets and data analysis tools to use in their studies, and an Analysis in Practice section added to each chapter facilitates hands-on experience working with data. A Practical Approach to Analyzing Healthcare Data, Third Edition, offers guidance to healthcare professionals and health information management (HIM) students on how to best analyze, categorize, and manage the data that they encounter in an industry becoming ever more dependent on these tasks. With expanded and reorganized content on statistical analysis techniques, and new content on value-based purchasing (VBP) analytics and risk adjustment, this text applies broader principles of data evaluation specifically to the field of HIM. Updated and augmented online resources give professionals and students access to actual data sets and data analysis tools to use in their studies, and an Analysis in Practice section added to each chapter facilitates hands-on experience working with data"--Publisher's description.
Download or read book Clinical Data Manager The Comprehensive Guide written by VIRUTI SHIVAN and published by Viruti Satyan Shivan. This book was released on with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, "Clinical Data Manager: The Comprehensive Guide" dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research.
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by . This book was released on 2017 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Practical Guide for Informationists written by Antonio P Derosa and published by Chandos Publishing. This book was released on 2018-02-24 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide for Informationists: Supporting Research and Clinical Practice guides new informationists to a successful career, giving them a pathway to this savvier, more technically advanced, domain-focused role in modern day information centers and libraries. The book's broad scope serves as an invaluable toolkit for healthcare professionals, researchers and graduate students in information management, library and information science, data management, informatics, etc. Furthermore, it is also ideal as a textbook for courses in medical reference services/medical informatics in MLIS programs.
Download or read book Clinical Data Manager The Comprehensive Guide written by Viruti Shivan and published by Viruti Shivan. This book was released on 2024-03-22 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mastering Data Integrity and Efficiency in Healthcare Research In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, "Clinical Data Manager: The Comprehensive Guide" dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research.
Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by James Currey. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Includes bibliographical references and index.
