Practical Guide To Clinical Data Management
DOWNLOAD
Download Practical Guide To Clinical Data Management PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Practical Guide To Clinical Data Management book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Practical Guide To Clinical Data Management
DOWNLOAD
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,
Practical Guide To Clinical Data Management Second Edition
DOWNLOAD
Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2006-08-01
Practical Guide To Clinical Data Management Second 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 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 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.
Medical Management A Practical Guide
DOWNLOAD
Author : Hameen Markar
language : en
Publisher: CRC Press
Release Date : 2012-08-31
Medical Management A Practical Guide written by Hameen Markar and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-08-31 with Business & Economics categories.
This essential guide provides a lifeline to authoritative, reliable information on medical management, giving you all the skills you need whether managing a junior colleague as a lead doctor, or running multidisciplinary consortia in the NHS or private sectors. Learn key skills from leadership, managing change, quality control, and project management through to doctors in difficulty, appraisals and revalidation, managing exceptional performance, and poor performance Comprehensive coverage of NHS and private healthcare, primary care, acute and emergency care, mental health, and many other sectors Gain insight into important topics such as healthcare innovations and technologies, implementing evidence-based medicine, medical education, patient safety, and primary care consortia Refine your management skills with advice, wisdom, and practical help from key opinion leaders, medical professionals, and management experts In this world of change, reforms and new government initiatives, can you afford not to build on your existing skills? Whether you are new to medical management or an experienced director wishing to stay up to date and refine your expertise, this book will be an invaluable source of advice to help you manage the delivery of high-quality care.
Practical Guide To Clinical Data Management
DOWNLOAD
Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 1999-01-31
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 1999-01-31 with Medical categories.
Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.
Clinical Trials
DOWNLOAD
Author : Stuart J. Pocock
language : en
Publisher: John Wiley & Sons
Release Date : 2013-07-17
Clinical Trials written by Stuart J. Pocock 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 2013-07-17 with Medical categories.
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.
Electronic Medical Records
DOWNLOAD
Author : Neil S. Skolnik
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-10-20
Electronic Medical Records written by Neil S. Skolnik 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 2010-10-20 with Medical categories.
Physician adoption of electronic medical records (EMRs) has become a national priority. It is said that EMRs have the potential to greatly improve patient care, to provide the data needed for more effective population management and quality assurance of both an individual practice’s patients and well as patients of large health care systems, and the potential to create efficiencies that allow physicians to provide this improved care at a far lower cost than at present. There is currently a strong U.S. government push for physicians to adopt EMR technology, with the Obama administration emphasizing the use of EMRs as an important part of the future of health care and urging widespread adoption of this technology by 2014. This timely book for the primary care community offers a concise and easy to read guide for implementing an EMR system. Organized in six sections, this invaluable title details the general state of the EMR landscape, covering the government’s incentive program, promises and pitfalls of EMR technology, issues related to standardization and the range of EMR vendors from which a provider can choose. Importantly, chapter two provides a detailed and highly instructional account of the experiences that a range of primary care providers have had in implementing EMR systems. Chapter three discusses how to effectively choose an EMR system, while chapters four and five cover all of the vital pre-implementation and implementation issues in establishing an EMR system in the primary care environment. Finally, chapter six discusses how to optimize and maintain a new EMR system to achieve the full cost savings desired. Concise, direct, but above all honest in recognizing the challenges in choosing and implementing an electronic health record in primary care, Electronic Medical Records: A Practical Guide for Primary Care has been written with the busy primary care physician in mind.
Clinical Prediction Models
DOWNLOAD
Author : Ewout W. Steyerberg
language : en
Publisher: Springer
Release Date : 2019-07-22
Clinical Prediction Models written by Ewout W. Steyerberg and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-22 with Medical categories.
The second edition of this volume provides insight and practical illustrations on how modern statistical concepts and regression methods can be applied in medical prediction problems, including diagnostic and prognostic outcomes. Many advances have been made in statistical approaches towards outcome prediction, but a sensible strategy is needed for model development, validation, and updating, such that prediction models can better support medical practice. There is an increasing need for personalized evidence-based medicine that uses an individualized approach to medical decision-making. In this Big Data era, there is expanded access to large volumes of routinely collected data and an increased number of applications for prediction models, such as targeted early detection of disease and individualized approaches to diagnostic testing and treatment. Clinical Prediction Models presents a practical checklist that needs to be considered for development of avalid prediction model. Steps include preliminary considerations such as dealing with missing values; coding of predictors; selection of main effects and interactions for a multivariable model; estimation of model parameters with shrinkage methods and incorporation of external data; evaluation of performance and usefulness; internal validation; and presentation formatting. The text also addresses common issues that make prediction models suboptimal, such as small sample sizes, exaggerated claims, and poor generalizability. The text is primarily intended for clinical epidemiologists and biostatisticians. Including many case studies and publicly available R code and data sets, the book is also appropriate as a textbook for a graduate course on predictive modeling in diagnosis and prognosis. While practical in nature, the book also provides a philosophical perspective on data analysis in medicine that goes beyond predictive modeling. Updates to this new and expanded edition include: • A discussion of Big Data and its implications for the design of prediction models • Machine learning issues • More simulations with missing ‘y’ values • Extended discussion on between-cohort heterogeneity • Description of ShinyApp • Updated LASSO illustration • New case studies
Implementation Research In Health
DOWNLOAD
Author : David H. Peters
language : en
Publisher: World Health Organization
Release Date : 2013
Implementation Research In Health written by David H. Peters and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Medical categories.
Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
A Practical Guide To Human Research And Clinical Trials
DOWNLOAD
Author : M. U. R. Naidu
language : en
Publisher: CRC Press
Release Date : 2013-01-29
A Practical Guide To Human Research And Clinical Trials written by M. U. R. Naidu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-29 with Medical categories.
Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.
Practical Guide To Medical Student Assessment
DOWNLOAD
Author : Zubair Amin
language : en
Publisher: World Scientific
Release Date : 2006-08-23
Practical Guide To Medical Student Assessment written by Zubair Amin and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-08-23 with Medical categories.
This practical guide provides a simple, useful reference to commonly raised questions about medical student assessment.The first part of the book provides succinct information on the general aspects of assessment such as purpose and principles of assessment; technical terms such as validity, reliability, and utility of assessment instruments; and how to choose assessment instruments for a given purpose.Individual assessment instruments are treated in the second part of the guide. The authors focus on about 20 selected assessment instruments currently in use or promising new instruments that are likely to get increased acceptance in future. For each instrument a general description is given, followed by discussion on its uses, limitations, psychometric characteristics, and recommendations for medical teachers.The reference section contains highly selective and well-researched resources, annotated and classified according to their usefulness. Many of these resources are available free on the Internet.