December 2, 2020

Download Ebook Free Research Regulatory Compliance

Research Regulatory Compliance

Research Regulatory Compliance
Author : Mark A. Suckow,Bill Yates
Publisher : Academic Press
Release Date : 2015-06-14
Category : Medical
Total pages :344
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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

Clinical Trials and Human Research

Clinical Trials and Human Research
Author : Fay A. Rozovsky, JD, MPH,Rodney K. Adams
Publisher : Jossey-Bass
Release Date : 2003-06-10
Category : Medical
Total pages :656
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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.

Research Ethics and Integrity for Social Scientists

Research Ethics and Integrity for Social Scientists
Author : Mark Israel
Publisher : SAGE
Release Date : 2014-10-20
Category : Reference
Total pages :264
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Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

Clinical Research Compliance Manual

Clinical Research Compliance Manual
Author : Brent,Aspen Publishers,Lawrence W. Vernaglia,Aspen
Publisher : Aspen Publishers
Release Date : 2007
Category : Medical
Total pages :588
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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!

Implementing a Comprehensive Research Compliance Program

Implementing a Comprehensive Research Compliance Program
Author : Aurali Dade,Lori Olafson,Suzan M. DiBella
Publisher : IAP
Release Date : 2015-07-01
Category : Education
Total pages :569
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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.

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Release Date : 2004-07-09
Category : Medical
Total pages :445
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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.

Impact of Regulatory Compliance Costs on Small Airports

Impact of Regulatory Compliance Costs on Small Airports
Author : Anonim
Publisher : Unknown
Release Date : 2013
Category : Airports
Total pages :84
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"TRB's Airport Cooperative Research Program (ACRP) Report 90: Impact of Regulatory Compliance Costs on Small Airports explores the cumulative costs of complying with regulatory and other federal requirements at small hub and non-hub airports."--Publisher's description.

Management of Animal Care and Use Programs in Research, Education, and Testing

Management of Animal Care and Use Programs in Research, Education, and Testing
Author : Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
Publisher : CRC Press
Release Date : 2017-09-07
Category : Medical
Total pages :872
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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).

Becoming A Successful Clinical Trial Investigator

Becoming A Successful Clinical Trial Investigator
Author : P. K. Julka
Publisher : Dna Press
Release Date : 2009-09-15
Category :
Total pages :172
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The Regulatory Compliance Almanac

The Regulatory Compliance Almanac
Author : Les Schnoll
Publisher : Paton Professional
Release Date : 2008
Category : Drugs
Total pages :549
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Research Ethics for Social Scientists

Research Ethics for Social Scientists
Author : Mark Israel,Iain Hay
Publisher : SAGE
Release Date : 2006-06-29
Category : Social Science
Total pages :193
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Ethics is becoming an increasingly prominent issue for all researchers across the western world. This comprehensive and accessible guide introduces students to the field and encourages knowledge of research ethics in practice. Research Ethics for Social Scientists sets out to do four things: The first is to demonstrate the practical value of thinking seriously and systematically about what constitutes ethical conduct in social science research. Second, the text identifies how and why current regulatory regimes have emerged. Third, it seeks to reveal those practices that have contributed to the adversarial relationships between researchers and regulators. Finally, the book hopes to encourage both parties to develop shared solutions to ethical and regulatory problems.

Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 1998-08-11
Category : Medical
Total pages :496
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"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

The Regulatory Environment for Science

The Regulatory Environment for Science
Author : Anonim
Publisher : Unknown
Release Date : 1986
Category : Government publications
Total pages :146
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The Regulatory environment for science.

The Regulatory environment for science.
Author : Anonim
Publisher : DIANE Publishing
Release Date : 2020
Category :
Total pages :129
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Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
Author : Rebecca Sheets
Publisher : Academic Press
Release Date : 2017-12-13
Category : Medical
Total pages :450
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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products