Designing A Research Compliance Program
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Designing A Research Compliance Program
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Author : Ernestoh Khomu
language : en
Publisher: GRIN Verlag
Release Date : 2017-05-29
Designing A Research Compliance Program written by Ernestoh Khomu and has been published by GRIN Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-29 with Medical categories.
Seminar paper from the year 2017 in the subject Health - Public Health, grade: 2, , course: Bachelor of Public Health, language: English, abstract: All successful clinical or healthcare research endeavors in the current era depend on a carefully designed oversight process. One integral part of the same is the Research Compliance Program. This paper skims trough some of the most basic parts of the Research Compliance Department as part of studies related to understanding the relationship between the Department itself and the program. I hope it accurately reveals new insight into the subject matter.
Implementing A Comprehensive Research Compliance Program
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Author : Aurali Dade
language : en
Publisher: IAP
Release Date : 2015-07-01
Implementing A Comprehensive Research Compliance Program written by Aurali Dade and has been published by IAP this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-01 with Education categories.
The senior research compliance administrator has emerged as a critically important position as universities and other research organizations face an increasingly intricate regulatory environment. These administrators are tasked with a special challenge: ensuring that their institutions conduct safe, ethical, and compliant research while also helping researchers understand and meet compliance requirements and achieve their research goals. These competing responsibilities can make the role of the research administrator complex; however, those who serve in this role may find that they have limited preparation for the challenges and little or no formal education in the field. Thus, the goal of this handbook is to provide practical guidance to research administrators who are responsible for a wide variety of compliance programs. Previous volumes on these topics have focused primarily on educating research faculty, staff, and students. An assumption in many of these handbooks is that all additional questions related to research ethics and regulations should be directed to the senior research administrator; yet, the books have limited guidance intended for the senior research administrators themselves. This handbook is designed, therefore, to serve as a detailed program implementation manual for these administrators, who are expected to be conversant on a broad range of complex ethical and regulatory topics and to provide guidance to those conducting research, as well as upper administration and others interested in safe, ethical, and compliant research.
Building A World Class Compliance Program
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Author : Martin T. Biegelman
language : en
Publisher: John Wiley & Sons
Release Date : 2008-06-20
Building A World Class Compliance Program written by Martin T. Biegelman 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 2008-06-20 with Business & Economics categories.
Written by a long-standing practitioner in the field, this timely and critical work is your best source for understanding all the complex issues and requirements associated with corporate compliance. It provides clear guidance for those charged with protecting their companies from financial and reputational risk, litigation, and government intervention, who want a robust guide to establish an effective compliance program.
Building And Sustaining A Hospital Based Nursing Research Program
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Author : Nancy Albert, PhD, CCNS, CCRN, NE-BC, FAHA, FCCM
language : en
Publisher: Springer Publishing Company
Release Date : 2015-11-13
Building And Sustaining A Hospital Based Nursing Research Program written by Nancy Albert, PhD, CCNS, CCRN, NE-BC, FAHA, FCCM and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-13 with Medical categories.
The first resource to present the “nuts and bolts” of creating a successful nursing research program. This text provides a roadmap to develop and nurture a nursing research program in complex hospital environments. Written by experienced clinical researchers who have successfully implemented these techniques in the Cleveland Clinic, the handbook shows nurses how to build and sustain a research program—a fundamental requirement to transform patient care and administrative practices and obtain and sustain American Nurses Credentialing Center Magnet® program recognition. The book demonstrates, step-by-step, how leaders and staff can integrate nursing research into the workflow of complex health care environments. It provides a framework for developing horizontal and vertical structures that promote the creation of new knowledge and for enhancing the scientific foundation of nursing evidence. With a focus on practical applications, the book addresses the structures, systems, processes, and resources required for creating and maintaining a research program along with methods for its evaluation. The handbook describes foundational principles that apply to hospitals of all sizes (including ambulatory centers and hospitals without extensive resources), and provides concrete guidance in adapting structures and processes to fit the needs of hospitals with varied nursing staff size and program goals. Replete with a wealth of ideas and strategies, it provides detailed templates that will assist novice and more experienced researchers, guidelines for committees to support nursing research within a hospital, and discusses the “who,” “what,” “why” of systems that enhance workflow. Chapters offer experiential stories written by nurses who describe the “real world” experiences of implementing clinical research in their practice. Tables and figures further illuminate information. Key Features: Written by experienced researchers who have implemented the techniques used in this book Provides a framework adaptable for use with hospitals of all sizes Includes guidelines for committees/councils to support nursing research within the organization Discusses processes and systems that enhance collaboration and workflow Offers stories from the field by nurses about “lessons learned” from their research experiences
Designing A Compliance Program At Ab Inbev
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Author : Eugene Soltes
language : en
Publisher:
Release Date : 2018
Designing A Compliance Program At Ab Inbev written by Eugene Soltes and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.
Legal Compliance Programs
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Author : Lynn S. Paine
language : en
Publisher:
Release Date : 2012
Legal Compliance Programs written by Lynn S. Paine and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with categories.
Describes the basic elements of a typical corporate compliance or ethics program, focusing on the components of an "effective" program set forth in the U.S. Organizational Sentencing Guidelines as revised in 2010. Outlines key issues in program design and implementation and provides an overview of relevant research.
Design And Analysis Of Clinical Trials
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Author : Shein-Chung Chow
language : en
Publisher: John Wiley & Sons
Release Date : 2008-12-04
Design And Analysis Of Clinical Trials written by Shein-Chung Chow 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 2008-12-04 with Mathematics categories.
Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
Research Administration And Management
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Author : Elliott C. Kulakowski
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2006-01-16
Research Administration And Management written by Elliott C. Kulakowski and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-16 with Medical categories.
This reference text addresses the basic knowledge of research administration and anagement, and includes everything from a review of research administration and the infrastructure that is necessary to support research, to project development and post-project plans. Examples of concepts, case studies, a glossary of terms and acronyms, and references to books, journal articles, monographs, and federal regulations are also included.
Management Of Animal Care And Use Programs In Research Education And Testing
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Author : Robert H. Weichbrod
language : en
Publisher: CRC Press
Release Date : 2017-09-07
Management Of Animal Care And Use Programs In Research Education And Testing written by Robert H. Weichbrod and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-07 with Medical categories.
AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).
National Traffic And Motor Vehicle Safety Act Of 1966 Legislative History Volume Iii
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Author :
language : en
Publisher:
Release Date : 1985
National Traffic And Motor Vehicle Safety Act Of 1966 Legislative History Volume Iii written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985 with categories.