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Implementing A Comprehensive Research Compliance Program
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Book Synopsis Implementing a Comprehensive Research Compliance Program by : Aurali Dade
Download or read book Implementing a Comprehensive Research Compliance Program written by Aurali Dade and published by IAP. This book was released on 2015-07-01 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Designing a Research Compliance Program by : Ernestoh Khomu
Download or read book Designing a Research Compliance Program written by Ernestoh Khomu and published by GRIN Verlag. This book was released on 2017-05-29 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Research Compliance Professional's Handbook, 3rd Edition by : Health Care Compliance Association
Download or read book Research Compliance Professional's Handbook, 3rd Edition written by Health Care Compliance Association and published by . This book was released on 2019-03 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Research Regulatory Compliance by : Mark A. Suckow
Download or read book Research Regulatory Compliance written by Mark A. Suckow and published by Academic Press. This book was released on 2015-06-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book
Book Synopsis Clinical Research Law and Compliance Handbook by : John E. Steiner
Download or read book Clinical Research Law and Compliance Handbook written by John E. Steiner and published by Jones & Bartlett Learning. This book was released on 2006 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: Law/Ethics
Book Synopsis Management of Animal Care and Use Programs in Research, Education, and Testing by : Robert H. Weichbrod
Download or read book Management of Animal Care and Use Programs in Research, Education, and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
Book Synopsis Real World Psychology by : Catherine A. Sanderson
Download or read book Real World Psychology written by Catherine A. Sanderson and published by John Wiley & Sons. This book was released on 2019-12-24 with total page 706 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real World Psychology balances comprehensive coverage of the key concepts in introductory psychology with a concise presentation style and engages students with current and interesting research that explores these concepts in real-life contexts. Real World Psychology features the incomparable author team of Karen Huffman (Palomar College) and Catherine Sanderson (Amherst College) who create an outstanding text that is appealing to students and instructors at a wide range of academic institutions. The new edition has been thoroughly updated and features a new focus on Scientific Thinking and Practical Applications underscoring the fact that connecting the principles of psychological science to everyday life is critical to student engagement, and ultimately key to their success – not only in the introductory psychology course, but in whatever their chosen field of study and in everyday life. Students will leave the course with an appreciation of how a basic, yet scientific understanding of human behavior can benefit them in their studies, in their personal lives, and in their professional endeavors.
Book Synopsis Psychological Science by : Catherine A. Sanderson
Download or read book Psychological Science written by Catherine A. Sanderson and published by John Wiley & Sons. This book was released on 2023-04-11 with total page 930 pages. Available in PDF, EPUB and Kindle. Book excerpt: Psychological Science: The Curious Mind, by award-winning authors and professors Catherine A. Sanderson and Karen Huffman, introduces 21st-century, digital-native students to the fascinating field of psychology. This new program emphasizes the importance of developing scientific literacy and an understanding of research and research methods. The program uses an inviting why-focused framework that taps into students' natural curiosity, incorporating active learning and real-life application to engage students. Psychological Science: The Curious Mind embraces the guidelines released by the American Psychological Association (APA)'s Introductory Psychology Initiative (IPI) in 2021. It provides an excellent framework for instructors who want to implement those guidelines in their Introductory Psychology courses, and it provides students with the content and motivation to achieve the course's ultimate outcome: an enduring, foundational understanding of psychological science.
Book Synopsis Real World Psychology by : Catherine Ashley Sanderson
Download or read book Real World Psychology written by Catherine Ashley Sanderson and published by John Wiley & Sons. This book was released on 2024 with total page 787 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Real World Psychology: Applications of Psychological Science, 4th Edition provides a complete, college-level survey of the field of psychology and an understanding of its scientific nature and research methods. As its title implies, the text emphasizes scientific thinking and practical applications of psychological science that can expand, enhance, and change students' experience of the real world around them. Updated with abundant new references since the 3rd edition's publication in 2019, this new edition highlights recent research that underscores the importance and power of psychology in our everyday lives and interactions, and the authors' careful and deliberate attention to issues of diversity, equity, and inclusion ensures the representation of multiple perspectives and experiences throughout a text in which all students can find respect and a sense of belonging."--
Book Synopsis Building a World-Class Compliance Program by : Martin T. Biegelman
Download or read book Building a World-Class Compliance Program written by Martin T. Biegelman and published by John Wiley & Sons. This book was released on 2008-06-20 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Ethics and Compliance Programs in Multinational Organizations by : Katharina Wulf
Download or read book Ethics and Compliance Programs in Multinational Organizations written by Katharina Wulf and published by Springer Science & Business Media. This book was released on 2012-02-21 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The study examines how multinational organizations implement the concept of ethics and compliance programs into their businesses and the extent to which these programs were geared to the 2004 Amendments. The study explores the applicability of the 2004 Amendments and analyzes the instruments organizations use to successfully develop and maintain these programs. By including research from various fields, a theoretical framework was developed for implementing an ethics and compliance program that takes into account the 2004 Amendments
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Book Synopsis Clinical Research Compliance Manual by : Patricia L. Brent
Download or read book Clinical Research Compliance Manual written by Patricia L. Brent and published by Aspen Publishers. This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including: Human subject protections Institutional Review Board regulations and requirements Conflicts of interest Scientific misconduct Reimbursement issues And much more! Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments: Covers the major clinical research issues - with chapters written by experts in the field Provides legal explanations of the major regulatory issues in an easy-to-understand format Includes summaries of federal regulatory agencies, analysis of major cases, flow-charts, checklists, and footnotes to in compliance program development, auditing and monitoring Clinical Research Compliance Manual has been updated to include: A new chapter on "Protecting Research Materials, Research Results, and Inventions: A University's Perspective" A new section on "Recent Proposed Changes to the Common Rule" Updated discussion of federal-wide assurance (FWA) OHRP's revision of its FAQs to be consistent with its Final Guidance on Engagement of Institutions in Human Subject Research Recent OHRP guidance on when institutions are not engaged in human subject research And much more!
Book Synopsis Clinical Research Compliance Manual by : Lawrence W. Vernaglia
Download or read book Clinical Research Compliance Manual written by Lawrence W. Vernaglia and published by Aspen Publishers. This book was released on 2020-10-21 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including: Human subject protections Institutional Review Board regulations and requirements Conflicts of interest Scientific misconduct Reimbursement issues And much more! Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments: Covers the major clinical research issues - with chapters written by experts in the field Provides legal explanations of the major regulatory issues in an easy-to-understand format Includes summaries of federal regulatory agencies, analysis of major cases, flowcharts, checklists, and footnotes to compliance program development, auditing and monitoring Clinical Research Compliance Manual has been updated to include: Discussion on the revised Common Rule Analysis of enforcement of the May 25, 2018 GDPR New information on HHS's updated informed consent in human subject research regulations commonly referred to as the "2018 Rules" Updated sections on NIH Supported Clinical Research, including a discussion of recent changes made to the Bayh-Dole Act of 1980 Revised sections on the categorization of medical devices as it pertains to reimbursement And much more!
Book Synopsis Managing Legal Compliance in the Health Care Industry by : George B. Moseley III
Download or read book Managing Legal Compliance in the Health Care Industry written by George B. Moseley III and published by Jones & Bartlett Publishers. This book was released on 2013-09-20 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Legal Compliance in the Health Care Industry is a comprehensive text that prepares students for this increasingly critical field in health care administration. In three sections, this unique title first examines all the key laws and regulations that health care organizations must comply with. In section two, it explores in detail the seven essential ingredients for a good compliance program. In the final section, the book explains how the compliance program must be adapted to the special needs of different types of health care organizations. Designed for graduate level students in programs of public health, health administration, and law, the text is filled with highly practical information about the ways that legal violations occur and how good compliance programs function. Key Features: - Examines in detail the current laws and regulations with which all types of health care organizations must comply - Explore the seven essential ingredients for a good compliance program - Looks at compliance programs within twelve different types of health care organizations - References real world cases of fraud and abuse - Includes Study Questions and Learning Experiences in each chapter that are designed to encourage critical thinking
Book Synopsis Responsible Conduct of Research by : Adil E. Shamoo
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Book Synopsis The Complete Compliance Handbook by : Thomas Fox
Download or read book The Complete Compliance Handbook written by Thomas Fox and published by . This book was released on 2018-05-05 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thomas Fox, the Compliance Evangelist, is one of the leading writers, thinkers and commentators on the nuts and bolts of compliance. His always practical advice is now available in one volume, The Complete Compliance Handbook. This book incorporates the most recent pronouncements and guidance from the Department of Justice, including 2017's Evaluation of Corporate Compliance Programs and FCPA Corporate Enforcement Policy, to provide the most up-to-date advice on what constitutes a best practices compliance program. In this single volume compendium, Fox brings together the tops ideas, topics and techniques you can incorporate your compliance program, literally in 31-days to more fully operationalize your compliance regime. If you want one volume to guide you in operationalizing compliance, this is it. The book is designed to provide you with a step-by-step guide to the design, creation, implementation of or enhancement to a compliance program. It begins with 31-days to a more effective compliance program. Each entry presents one thing you can accomplish, at little to no cost, to improve any level of compliance program. There are three key-takeaways for each entry. The final chapter goes through the same process for you to operationalize your compliance program. In between these bookends, The Complete Compliance Handbook features chapters on: -Operationalizing Compliance Through Human Resources -The Role of the Board of Directors and Compliance -360-Degrees of Communication in Compliance -Better Third-Party Risk Management -Reporting and Investigations -Internal Controls -Innovation in Compliance -Written Standards -More Effective Compliance for Business Ventures -Continuous Improvement The author, Thomas Fox, has written 15 books on compliance, leadership and business ethics. He founded the Compliance Podcast Network and has one of the largest social media presences in compliance. He has worked in the compliance arena for over 10 years and draws upon his many years of experience in the profession to create this single volume which will become the standard 'nuts and bolts' text on compliance. Fox's writing style is suited for any skill level of compliance practitioner or maturity of corporate compliance program.
