Research Compliance Professional's Handbook, Second Edition
Author:
Publisher:
Published: 2013-11-01
Total Pages: 180
ISBN-13: 9780991078301
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Research Compliance Professional's Handbook, 3rd Edition
Author: Health Care Compliance Association
Publisher:
Published: 2019-03
Total Pages:
ISBN-13: 9781733598613
DOWNLOAD EBOOKEnvironmental Compliance Handbook
Author: Jacob I. Bregman
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 434
ISBN-13: 1420032402
DOWNLOAD EBOOKIf your organization was subject to the thousands of federal, state, and local environmental laws and regulations in effect in the U.S. at the turn of the century, the Environmental Compliance Handbook should be within easy reach. Thousands of professionals have benefited from the bestselling classic. This practical, comprehensive book simplifies t
Implementing a Comprehensive Research Compliance Program
Author: Aurali Dade
Publisher: IAP
Published: 2015-07-01
Total Pages: 568
ISBN-13: 1681231336
DOWNLOAD EBOOKThe 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.
The Complete Compliance Handbook
Author: Thomas Fox
Publisher:
Published: 2018-05-05
Total Pages: 554
ISBN-13: 9781783583300
DOWNLOAD EBOOKThomas 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.
The Health Care Compliance Professional's Manual
Author: Hcca
Publisher: Aspen Publishers
Published: 2007
Total Pages: 1080
ISBN-13: 9780735570382
DOWNLOAD EBOOKThe Health Care Compliance Professional's Manual gives you all the tools you need to plan and execute a customized compliance program that meets federal standards. It walks you through the entire process, start to finish, showing you how to draft compliance policies, build a strong compliance infrastructure in your organization, document your efforts, apply self-assessment techniques, create an effective education program, pinpoint areas of risk, conduct internal probes and much more. The Health Care Compliance Professional's Manual is used by the Health Care Compliance Association (HCCA) as the basic text for its Compliance Academy - the program that prepares compliance professionals for the CHC (Certificate in Healthcare Compliance) certification exam. The Health Care Compliance Professional's Manual will help you to: Use OIG publications and Federal Sentencing Guidelines to help plan and execute a customized compliance strategy that meets tough federal standards Perform risk assessment to pinpoint areas within your company that pose compliance and operational risks Draft compliance policies that form the foundation for a strong compliance program Build a strong infrastructure for compliance to work, including hiring the right personnel Create an effective education and training program that instills in employees the value of legal compliance Conduct internal probes that uncover legal violations before the federal government does - and mitigate possible penalties Stay up-to-date on all the latest legal and regulatory requirements affecting your facility, including HIPAA, EMTALA, fraud and abuse reimbursement, privacy, security, patient safety and much more! Packed with tools to make your job easier, The Health Care Compliance Professional's Manual will provide: Practical coverage of federal and state laws governing your facility Document efforts and apply self assessment techniques Insight into helpful federal standards on effective compliance programs Step-by-step guidance on implementing a sound compliance program Time-saving sample compliance policies, forms, checklists, and chart The Health Care Compliance Professional's Manual will protect your company if violations do occur: Learn how to apply auditing, monitoring, and self-assessment techniques Discover how to successfully follow the OIG's voluntary disclosure program to resolve overpayment problems and avoid exclusion from Medicare Find out how to enter into a corporate integrity agreement to settle with the federal government and mitigate FCA-related penalties Document your compliance efforts so you leave a protective paper trail that shields you from liability And much more
The DevOps Handbook
Author: Gene Kim
Publisher: IT Revolution
Published: 2016-10-06
Total Pages: 515
ISBN-13: 194278807X
DOWNLOAD EBOOKIncrease profitability, elevate work culture, and exceed productivity goals through DevOps practices. More than ever, the effective management of technology is critical for business competitiveness. For decades, technology leaders have struggled to balance agility, reliability, and security. The consequences of failure have never been greater―whether it's the healthcare.gov debacle, cardholder data breaches, or missing the boat with Big Data in the cloud. And yet, high performers using DevOps principles, such as Google, Amazon, Facebook, Etsy, and Netflix, are routinely and reliably deploying code into production hundreds, or even thousands, of times per day. Following in the footsteps of The Phoenix Project, The DevOps Handbook shows leaders how to replicate these incredible outcomes, by showing how to integrate Product Management, Development, QA, IT Operations, and Information Security to elevate your company and win in the marketplace.
Clinical Research Compliance Manual
Author: Lawrence W. Vernaglia
Publisher: Aspen Publishers
Published: 2019-11-17
Total Pages: 776
ISBN-13: 9781543817553
DOWNLOAD EBOOKFor 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! Previous Edition: Clinical Research Compliance Manual: An Administrative Guide, Second Edition, ISBN 9781543806724
Healthcare Interoperability Standards Compliance Handbook
Author: Frank Oemig
Publisher: Springer
Published: 2016-12-18
Total Pages: 696
ISBN-13: 3319448390
DOWNLOAD EBOOKThis book focuses on the development and use of interoperability standards related to healthcare information technology (HIT) and provides in-depth discussion of the associated essential aspects. The book explains the principles of conformance, examining how to improve the content of healthcare data exchange standards (including HL7 v2.x, V3/CDA, FHIR, CTS2, DICOM, EDIFACT, and ebXML), the rigor of conformance testing, and the interoperability capabilities of healthcare applications for the benefit of healthcare professionals who use HIT, developers of HIT applications, and healthcare consumers who aspire to be recipients of safe and effective health services facilitated through meaningful use of well-designed HIT. Readers will understand the common terms interoperability, conformance, compliance and compatibility, and be prepared to design and implement their own complex interoperable healthcare information system. Chapters address the practical aspects of the subject matter to enable application of previously theoretical concepts. The book provides real-world, concrete examples to explain how to apply the information, and includes many diagrams to illustrate relationships of entities and concepts described in the text. Designed for professionals and practitioners, this book is appropriate for implementers and developers of HIT, technical staff of information technology vendors participating in the development of standards and profiling initiatives, informatics professionals who design conformance testing tools, staff of information technology departments in healthcare institutions, and experts involved in standards development. Healthcare providers and leadership of provider organizations seeking a better understanding of conformance, interoperability, and IT certification processes will benefit from this book, as will students studying healthcare information technology.
Clinical Trials and Human Research
Author: Fay A. Rozovsky
Publisher: Jossey-Bass
Published: 2003-06-10
Total Pages: 0
ISBN-13: 9780787965709
DOWNLOAD EBOOKThis 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.
