research regulatory compliance

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Research Regulatory Compliance

Author : Mark A. Suckow
ISBN : 9780124200654
Genre : Medical
File Size : 45. 18 MB
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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

The Handbook Of Patient Safety Compliance

Author : Fay A. Rozovsky
ISBN : 9780787978686
Genre : Medical
File Size : 56. 12 MB
Format : PDF, ePub, Mobi
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Written for virtually every professional and leader in the healthcare field, as well as students who are preparing for careers inhealth services delivery, this book presents a framework fordeveloping a patient safety program, shows how best to examineevents that do occur, and reveals how to ensure that appropriatecorrective and preventative actions are reviewed for effectiveness.The book covers a comprehensive selection of topics including The link between patient safety and legal and regulatorycompliance The role of accreditation and standard-setting organizations inpatient safety Failure modes and effect analysis Voluntary and regulatory oversight of medical error Evidence-based outcomes and standards of care Creation and preservation of reports, data, and device evidencein medical error situations Claims management when dealing with patient safety events Full disclosure Patient safety in human research Managing confidentiality in the face of litigation Managing patient safety compliance through accountability-basedcredentialing for health care professionals Planning for the future

Hazardous Materials Compliance For Public Research Organizations

Author : Nicolas A. Valcik
ISBN : 9781466509474
Genre : Science
File Size : 40. 28 MB
Format : PDF, Kindle
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Completely revised and updated, Hazardous Materials Compliance for Public Research Organizations: A Case Study, Second Edition presents a case study of one university’s policies and practices with regard to the procurement, use, storage and disposal of HAZMAT in the context of a changing internal structure and regulatory environment. The author’s presentation is no-holds-barred, using interviews, archival documentation, and unobtrusive observations as a participant where the research institution was at times noncompliant with the new federal guidelines. See What’s New in the Second Edition: Incorporates issues with all types of hazardous materials instead of just focusing on biological HAZMAT Updated information on current regulations on HAZMAT in relation to universities and research centers Follow-up on the case study university, disclosing the university’s progress in resolving the security and safety shortcomings By implementing key improvements in safety and security, the universities can also more easily obtain research grant money and satisfy both state and federal safety requirements. This book includes recommendations to improve safety while using and storing biotoxins, chemical, radioactive material, and industrial waste, and to improve overall security at the university. It also highlights improvements that can make the environment a safer and more secure location to perform biological research.

Principles Of Risk Management And Patient Safety

Author : Barbara J. Youngberg
ISBN : 9781449618834
Genre : Medical
File Size : 20. 55 MB
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Principles of Risk Management and Patient Safety identifies changes in the industry and describes how these changes have influenced the functions of risk management in all aspects of healthcare. The book is divided into four sections. The first section describes the current state of the healthcare industry and looks at the importance of risk management and the emergence of patient safety. It also explores the importance of working with other sectors of the health care industry such as the pharmaceutical and device manufacturers. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition.

Ethical Conduct Of Clinical Research Involving Children

Author : Institute of Medicine
ISBN : 9780309091817
Genre : Medical
File Size : 39. 8 MB
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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.

Clinical Research Law And Compliance Handbook

Author : John E. Steiner
ISBN : 0763747254
Genre : Business & Economics
File Size : 30. 73 MB
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Written in clear, practical language, this title will help you navigate the clinical research maze as it addresses critically important legal, operational, ethical and business issues associated with clinical research trials.

Research Ethics And Integrity For Social Scientists

Author : Mark Israel
ISBN : 9781473909168
Genre : Social Science
File Size : 78. 33 MB
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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.

Compliance Management In Financial Industries

Author : Mathias Eggert
ISBN : 9783319039138
Genre : Business & Economics
File Size : 84. 88 MB
Format : PDF
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Since the peak of the world financial crisis in 2008, compliance management has gained more and more interest from practice and research. In particular the financial service industry is strongly regulated and has to follow specific laws, standards and guidelines. Considering the steadily increasing number of legal requirements in the design of information systems is a challenge to financial service providers. This book investigates the challenges of compliance management in financial industries and provides solutions for a compliant design of information models. From a business process perspective, an approach is presented that enables the automatic checking of business process models. From a supervisory reporting perspective a modeling technique is presented that allows for modeling regulatory data warehouse requirements as well as its analysis. Besides these two perspectives the author provides insights into the perceived relationship of Information Systems and Law.

Measuring The Statutory And Regulatory Constraints On Dod Acquisition Research Design For An Empirical Study

Author : Jeffrey A. Drezner
ISBN : 9780833039675
Genre : Political Science
File Size : 58. 55 MB
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The Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics asked RAND to evaluate the cost of compliance with acquisition-related statutes and regulations at the program office level. This report identifies the areas considered most burdensome and describes the study's methodology, focus, and data collection process, including the development of a Web-based data collection tool for use by program office personnel.

Oecd Regulatory Compliance Cost Assessment Guidance

Author : OECD
ISBN : 9789264209657
Genre :
File Size : 56. 44 MB
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This guidance document provides a practical, technical and user-friendly guidance on measuring and reducing compliance costs of regulation in OECD countries.

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