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 2011-10-26 with total page 296 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,

Download or read book Medical Data Management written by Florian Leiner and published by Springer Science & Business Media. This book was released on 2003-01-14 with total page 230 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 HIMSS Dictionary of Healthcare Information Technology Terms Acronyms and Organizations Third Edition written by HIMSS and published by HIMSS. This book was released on 2013 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This bestselling health IT dictionary has been significantly expanded in its third edition. This timely dictionary has been developed and extensively reviewed by more than 50 industry experts. It contains more than 2,900 health IT and related terms and acronyms, and includes mission summaries and contact information for more than 330 healthcare organizations and associations. The HIMSS Dictionary of Healthcare Information Technology Terms, Acronyms and Organizationsis the ideal quick reference for health IT professionals and the essential resource for executives, clinicians, academics, consultants, government staff and other professionals who need a reference tool for understanding the terminology and acronyms for this growing field. This valuable resource includes: definition of terms for the information technology and clinical, medical, and nursing informatics fields; acronyms with cross-references to current definitions; a list of health IT-related associations and organizations, including contact information, mission statements, and web addresses; academic and certification credentials used in healthcare.

Download or read book Process Validation in Manufacturing of Biopharmaceuticals Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Download or read book Data Mining Concepts and Techniques written by Jiawei Han and published by Elsevier. This book was released on 2011-06-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data Mining: Concepts and Techniques provides the concepts and techniques in processing gathered data or information, which will be used in various applications. Specifically, it explains data mining and the tools used in discovering knowledge from the collected data. This book is referred as the knowledge discovery from data (KDD). It focuses on the feasibility, usefulness, effectiveness, and scalability of techniques of large data sets. After describing data mining, this edition explains the methods of knowing, preprocessing, processing, and warehousing data. It then presents information about data warehouses, online analytical processing (OLAP), and data cube technology. Then, the methods involved in mining frequent patterns, associations, and correlations for large data sets are described. The book details the methods for data classification and introduces the concepts and methods for data clustering. The remaining chapters discuss the outlier detection and the trends, applications, and research frontiers in data mining. This book is intended for Computer Science students, application developers, business professionals, and researchers who seek information on data mining. - Presents dozens of algorithms and implementation examples, all in pseudo-code and suitable for use in real-world, large-scale data mining projects - Addresses advanced topics such as mining object-relational databases, spatial databases, multimedia databases, time-series databases, text databases, the World Wide Web, and applications in several fields - Provides a comprehensive, practical look at the concepts and techniques you need to get the most out of your data

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second 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

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Healthcare Information Management Systems written by Marion J. Ball and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at health care professionals, this book looks beyond traditional information systems and shows how hospitals and other health care providers can attain a competitive edge. Speaking practitioner to practitioner, the authors explain how they use information technology to manage their health care institutions and to support the delivery of clinical care. This second edition incorporates the far-reaching advances of the last few years, which have moved the field of health informatics from the realm of theory into that of practice. Major new themes, such as a national information infrastructure and community networks, guidelines for case management, and community education and resource centres are added, while such topics as clinical and blood banking have been thoroughly updated.

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 Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing Clinical Research 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—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

Download or read book Clinical Analytics and Data Management for the DNP written by Martha L. Sylvia, PhD, MBA, RN and published by Springer Publishing Company. This book was released on 2023-01-18 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 unique text and reference—the only book to address the full spectrum of clinical data management for the DNP student—instills a fundamental understanding of how clinical data is gathered, used, and analyzed, and how to incorporate this data into a quality DNP project. The new third edition is updated to reflect changes in national health policy such as quality measurements, bundled payments for specialty care, and Advances to the Affordable Care Act (ACA) and evolving programs through the Centers for Medicare and Medicaid Services (CMS). The third edition reflects the revision of 2021 AACN Essentials and provides data sets and other examples in Excel and SPSS format, along with several new chapters. This resource takes the DNP student step-by-step through the complete process of data management, from planning through presentation, clinical applications of data management that are discipline-specific, and customization of statistical techniques to address clinical data management goals. Chapters are brimming with descriptions, resources, and exemplars that are helpful to both faculty and students. Topics spotlight requisite competencies for DNP clinicians and leaders such as phases of clinical data management, statistics and analytics, assessment of clinical and economic outcomes, value-based care, quality improvement, benchmarking, and data visualization. A progressive case study highlights multiple techniques and methods throughout the text. New to the Third Edition: New Chapter: Using EMR Data for the DNP Project New chapter solidifies link between EBP and Analytics for the DNP project New chapter highlights use of workflow mapping to transition between current and future state, while simultaneously visualizing process measures needed to ensure success of the DNP project Includes more examples to provide practical application exercises for students Key Features: Disseminates robust strategies for using available data from everyday practice to support trustworthy evaluation of outcomes Uses multiple tools to meet data management objectives [SPSS, Excel®, Tableau] Presents case studies to illustrate multiple techniques and methods throughout chapters Includes specific examples of the application and utility of these techniques using software that is familiar to graduate nursing students Offers real world examples of completed DNP projects Provides Instructor’s Manual, PowerPoint slides, data sets in SPSS and Excel, and forms for completion of data management and evaluation plan

Download or read book Management of Healthcare Organizations written by Peter Olden and published by Gateway to Healthcare Manageme. This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Management of Healthcare Organizations: An Introduction provides an integrated, practical approach to management that is applicable to all kinds of healthcare organizations. The book prepares future managers and leaders to assess situations and develop solutions with confidence. -- Publisher's website.

Download or read book Healthcare Operations Management written by Daniel B. McLaughlin and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Evaluation of Quality in Health Care for DNPs Third Edition written by Joanne V. Hickey, PhD, RN, FAAN, FCCM and published by Springer Publishing Company. This book was released on 2021-07-06 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its third edition, this award-winning text work is the only advanced practice nursing text to present effective, systematic, and in-depth evaluations of all aspects of health care quality. Comprehensive in scope, it distills best practice information from numerous sources to facilitate utmost competency for APN and DNP graduates. The third edition keeps pace with the rapidly evolving healthcare market by presenting a more comprehensive range of evaluation strategies for analyzing quality, safety, and value in healthcare practice and programs. It provides a completely new chapter on evaluation of simulation programs to improve clinician competency and patient care technology. An increased focus on the application of quality improvement is woven throughout, including the quality improvement-research continuum and an emphasis on interdisciplinary collaboration and teamwork. New case studies, specific examples from a variety of QI projects, and content specifically geared to improve teamwork also add to the book’s outstanding value. The text also delves into the theoretical basis of evaluation and its application as an integral part of contemporary practice. It includes evaluation models that enable nurses to address economic and financial viability, and guides readers through the translation of outcomes from evaluation into health care policy. Additionally, the text now includes PowerPoints for instructors. New to the Third Edition: New chapter: Evaluation of Simulation to Support Ongoing Competency in the HC Workforce Additional case studies and specific examples from QI projects Increased focus on teamwork and collaboration Enhanced discussion of theoretical foundations of evaluation approaches New focus on program evaluation and dissemination of findings Key Features: Addresses AACN competencies and scope of practice Helps students integrate best and evidence-based practices into care Provides guidance on practical methods and tools for Quality Improvement Project Presents evaluation models enabling nurses to address economic and financial viability Includes evaluations of organizations, systems, standards for practice, health care redesign, and the challenges of electronic medical records

Download or read book CPHIMS Review Guide written by Himss and published by CRC Press. This book was released on 2016-07-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether you're taking the CPHIMS exam, or simply want the most current and comprehensive overview in healthcare information and management systems today - this completely revised and updated third edition has it all. But for those preparing for the CPHIMS exam, this book is an ideal study partner. The content reflects the exam content outline covering healthcare and technology environments; systems analysis, design, selection, implementation, support, maintenance, testing, evaluation, privacy and security; and administration leadership management. Candidates can challenge themselves with the sample multiple choice questions at the end of the book.

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