A Practical Guide To Quality Management In Clinical Trial Research
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A Practical Guide To Quality Management In Clinical Trial Research
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Author : Graham Ogg
language : en
Publisher: CRC Press
Release Date : 2005-11-01
A Practical Guide To Quality Management In Clinical Trial Research written by Graham Ogg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-01 with Medical categories.
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
Clinical Trials And Human Research
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Author : Fay A. Rozovsky
language : en
Publisher: Jossey-Bass
Release Date : 2003-06-10
Clinical Trials And Human Research written by Fay A. Rozovsky and has been published by Jossey-Bass this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-06-10 with Medical categories.
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.
A Practical Guide To Managing Clinical Trials
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Author : JoAnn Pfeiffer
language : en
Publisher: CRC Press
Release Date : 2017-05-18
A Practical Guide To Managing Clinical Trials written by JoAnn Pfeiffer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-18 with Mathematics categories.
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.
Biotechnology Operations
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Author : John M. Centanni
language : en
Publisher: CRC Press
Release Date : 2016-09-19
Biotechnology Operations written by John M. Centanni and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-19 with Medical categories.
This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
A Comprehensive And Practical Guide To Clinical Trials
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Author : Delva Shamley
language : en
Publisher: Academic Press
Release Date : 2017-06-07
A Comprehensive And Practical Guide To Clinical Trials written by Delva Shamley and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-07 with Medical categories.
A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. - Describes the entire clinical trial management process from start to finish in a step-by-step guide - Provides best practice elements, including case studies, practical examples, activities, and checklists
A Practical Guide To Global Point Of Care Testing
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Author : Mark Shephard OAM
language : en
Publisher: CSIRO PUBLISHING
Release Date : 2016-11
A Practical Guide To Global Point Of Care Testing written by Mark Shephard OAM and has been published by CSIRO PUBLISHING this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11 with Medical categories.
Point-of-care testing (POCT) refers to pathology testing performed in a clinical setting at the time of patient consultation, generating a rapid test result that enables informed and timely clinical action to be taken on patient care. It offers patients greater convenience and access to health services and helps to improve clinical outcomes. POCT also provides innovative solutions for the detection and management of chronic, acute and infectious diseases, in settings including family practices, Indigenous medical services, community health facilities, rural and remote areas and in developing countries, where health-care services are often geographically isolated from the nearest pathology laboratory. A Practical Guide to Global Point-of-Care Testing shows health professionals how to set up and manage POCT services under a quality-assured, sustainable, clinically and culturally effective framework, as well as understand the wide global scope and clinical applications of POCT. The book is divided into three major themes: the management of POCT services, a global perspective on the clinical use of POCT, and POCT for specific clinical settings. Chapters within each theme are written by experts and explore wide-ranging topics such as selecting and evaluating devices, POCT for diabetes, coagulation disorders, HIV, malaria and Ebola, and the use of POCT for disaster management and in extreme environments. Figures are included throughout to illustrate the concepts, principles and practice of POCT. Written for a broad range of practicing health professionals from the fields of medical science, health science, nursing, medicine, paramedic science, Indigenous health, public health, pharmacy, aged care and sports medicine, A Practical Guide to Global Point-of-Care Testing will also benefit university students studying these health-related disciplines.
Practical Guide To Clinical Data Management Third Edition
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
Practical Guide To Clinical Data Management Third 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 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, 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.
Implementation Research In Health
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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.
Biophysical Chemistry Of Proteins
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Author : Engelbert Buxbaum
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-11-18
Biophysical Chemistry Of Proteins written by Engelbert Buxbaum 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 2010-11-18 with Science categories.
The book is structured in nine sections, each containing several chapters. The volume starts with an overview of analytical techniques and progresses through purification of proteins; protein modification and inactivation; protein size, shape, and structure; enzyme kinetics; protein-ligand interactions; industrial enzymology; and laboratory quality control. The book is targeted at all scientists interested in protein research.
The Duty For Sponor Oversight In Clinical Trials
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Author : Doris Breiner
language : en
Publisher: BoD – Books on Demand
Release Date : 2022-12-22
The Duty For Sponor Oversight In Clinical Trials written by Doris Breiner and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-22 with Science categories.
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.