Download or read book The Healthcare Compliance Professional s Guide to Clinical Trials written by F. Lisa Murtha and published by Hcpro, a Division of Simplify Compliance. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Billing for clinical trials is a focal point of government scrutiny, with several new CMS directives that mandate compliance with regulations for hospitals and university research facilities. The Healthcare Compliance Professional's Guide to Clinical Trials helps you sort through the various rules and establish policies and procedures that ensure Medicare-covered research is reimbursed appropriately. Professional's Guide to Clinical Trials Written by the Huron Consulting Group, a team of clinical research compliance experts, The Healthcare Compliance Professional's Guide to Clinical Trials will help ensure that your facility minimizes its compliance risk in the important research that it conducts. With this book, you can: *Customize forms to conduct a Medicare Coverage Analysis *Develop your own review plan based on proven sample auditing and monitoring templates *Analyze recent changes to the National Coverage Determination *Apply concepts from real-life clinical trial situations to your compliance program *Coordinate research and revenue teams The sample materials in this guide can be used right away. Download them from the companion CD-ROM and customize each document to fit your specific needs. It's that easy to develop a plan to ensure that your clinical trial research conforms to CMS regulations and that you receive the proper reimbursement.

Download or read book The Healthcare Compliance Professional s Guide to Policies and Procedures written by Richard P. Kusserow and published by Hcpro, a Division of Simplify Compliance. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ready-made compliance policies and procedures that you can adapt to your facility. Policies and procedures are the backbone of any compliance program. Compliance professionals must ensure that their policies and procedures are effective and up to date. To ensure effectiveness, the OIG expects hospitals to regularly re-evaluate their policies and procedures. Insight from a former Inspector General The Healthcare Compliance Professional's Guide to Policies and Procedures is written by former Inspector General Richard P. Kusserow. He has filled this book with sample policies and procedures that hospitals can use to strengthen their existing compliance program or help build a new one. Customize your program immediately The Healthcare Compliance Professional's Guide to Policies and Procedures provides the easy-to-use policies and procedures you need to ensure that your compliance program runs efficiently and smoothly. With these tools you will be able to: Implement proven, effective policies and procedures by using the sample templates provided Instruct staff with easy-to-comprehend instructions regarding policy and procedure development Identify best practices for policy and procedure development that are most likely to pass OIG investigation Ensure your policies are up to date with all legislation passed through the beginning of 2008 All of these sample policies and procedures can be used right away. Download our sample policies directly from the companion CD-ROM. You can then customize each document to fit your specific situation. It's that easy to develop a proven, effective set of policies and procedures! Take a look at the table of contents to see the variety of sample policies and procedures you will receive with The Healthcare Compliance Professional's Guide to Policies and Procedures: Compliance program oversight policies and procedures Compliance officer duties and responsibilities Confidentiality agreements Compliance officer and legal counsel protocol Records management Standards of conduct Ethics Compliance education and training Billing and coding policies Accurate coding Observation status Accurate documentation Prohibition of fraudulent and abusive billing Medicare's "incident to" rule Charity/uninsured care Medical necessity How to check for medical necessity ABN use for items and services that do not meet medical necessity Conflicts of interest agreements Gifts Vendor relationships Discounts/professional courtesies Reporting compliance problems Hotline use Hotline auditing Responses to complaints Nonretaliation policy (whistleblower protection) Auditing and monitoring Procedures for documenting auditing and monitoring Standards for auditing and monitoring Policies specific to laws and regulations Stark Anti-kickback statute False Claims Act Deficit Reduction Act EMTALA HIPAA Other risk areas Quality of care Clinical trials

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:

Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-05-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.

Download or read book Complete Healthcare Compliance Manual 2021 written by and published by . This book was released on 2021-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Clinical Trials and Human Research written by Fay A. Rozovsky and published by Jossey-Bass. This book was released on 2003-06-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

Download or read book HIPAA in Clinical Trials written by Lawrence H. Muhlbaier and published by Hcpro Incorporated. This book was released on 2003 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book and companion CD-ROM, HIPAA in Clinical Trials: A Practical Guide for Research Compliance, is an understandable, easy-to-read resource that describes the HIPAA privacy regulations as they apply to research, and how they relate to regulations already in place. HIPAA in Clinical Trials brings together all the HIPAA regulations relating to research, making it a tool to maintain compliance in a wide variety of research situations. Whether new to HIPAA or looking to take one's knowledge to the next level, HIPAA in Clinical Trials: A Practical Guide for Research Compliance will help the reader: *Understand what HIPAA means for clinical trials through clear, plain-English interpretations of the regulation. *Use included case scenarios as guideposts for compliance. *Create customized policies and procedures for research facility quickly by downloading and modifying samples on the CD-ROM. *Manage difficult research situations that have been impacted by HIPAA, such as dealing with operations staff. *Grasp research-specific HIPAA topics such as authorizations, pre-screening processes, and de-identified information. *Use the book's best-practice advice to navigate the areas of HIPAA that have been "hanging up" researchers.

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Download or read book A Practical Guide to Quality Management in Clinical Trial Research written by Graham Ogg and published by CRC Press. This book was released on 2005-11-01 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co

Download or read book Health Care Compliance Professional s Manual written by Wolters Kluwer and the American Health Law Association  and published by Aspen Publishers. This book was released on 2020-03-10 with total page 1654 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Health Care Compliance Professional's Manual is one of the most vital, long-standing, and best known resources in the world of health care compliance. It has all the tools you and your compliance team need to plan and execute a customized compliance program. This new edition is filled with industry best practices, sample forms, policies, procedures, and much more to save you time and comply with federal standards. The Health Care Compliance Professional's Manual will help you to: Use OIG publications and Federal Sentencing Guidelines to plan and execute a customized compliance strategy that meets tough federal standards and minimizes enforcement risks Oversee physician compensation and referrals Perform risk assessments using matrixes with step-by-step instructions to pinpoint areas that pose compliance and operational risks Draft compliance policies that form the foundation for a strong compliance program Build a strong infrastructure reinforced by industry best practices Create an effective education and training program that instills in employees the importance of legal compliance Implement a privacy and security plan that ensures patient information is protected Stay up-to-date on the latest legal and state and federal regulatory requirements affecting your facility, in areas such as HIPAA, EMTALA, fraud and abuse, reimbursement, privacy, security, patient safety, and clinical research Study for CCB(R) Certification in Healthcare Compliance (CHC) Packed with tools to make your job easier and more efficient, The Health Care Compliance Professional's Manual will provide: Practical coverage of federal and state laws governing your facility Insight into helpful federal standards on effective compliance programs Step-by-step guidance on implementing a sound compliance program Examples of common risk areas and how to handle them Time savings and peace of mind from sample policies, checklists and forms from members of the American Health Law Association (AHLA) The Health Care Compliance Professional's Manual will help you protect your company if violations do occur: Learn how to apply auditing, monitoring, and self-assessment techniques for conducting internal investigations 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 Previous Edition: Health Care Compliance Professional's Manual, Second Edition ISBN: 9781543813265 SKU: 10071961-7777

Download or read book Clinical Trials Explained written by David J. Kerr and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: What will happen during and after a clinical trial? How will a trial affect my quality of life? What are the benefits and risks of a trial? What does giving consent mean and what will it involve? Will I incur costs during and because of the trial? These are the questions that should be raised every time a health care professional talks through with a patient the pros and cons of entering a clinical trial. Clinical Trials Explained has been designed in consultation with doctors and patients who have taken part in trials, providing an essential and detailed guide to the clinical trials process. It therefore helps both clinicians and patients make well-informed decisions on whether to take part in a clinical trial.

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

Download or read book The Health Care Compliance Professional s Manual written by Hcca and published by Aspen Publishers. This book was released on 2007 with total page 1080 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 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

Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Download or read book Clinical Research Associate The Comprehensive Guide written by VIRUTI SHIVAN and published by Viruti Satyan Shivan. This book was released on with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a rapidly evolving field where precision and expertise can shape the future of healthcare, "Clinical Research Associate - The Comprehensive Guide" emerges as an indispensable resource for aspiring and established professionals alike. This guide dives deep into the heart of clinical trial management, offering a treasure trove of knowledge that spans the foundational basics to the intricacies of regulatory compliance, patient recruitment, data integrity, and beyond. With a focus on real-world applications and best practices, the book equips readers with the tools and insights needed to excel in their roles, navigate the challenges of the industry, and contribute to groundbreaking medical research. Given the specialized content, this guide intentionally omits images or illustrations to ensure a seamless reading experience while avoiding copyright issues, allowing the text to shine in its meticulous detail and expertly crafted narrative. The landscape of clinical research is one of constant innovation and stringent standards, making the role of the Clinical Research Associate more crucial than ever. This guide is not just a manual; it's a mentor in print, offering a blend of technical know-how, ethical considerations, and career advice to mold the next generation of industry leaders. Without the distraction of images or illustrations, every page invites the reader into a focused journey through the complexities and triumphs of clinical research. Whether you're taking your first steps in this dynamic field or looking to refine your expertise, this book stands as a beacon of knowledge, illuminating the path to excellence in clinical trial management.

Download or read book A Concise Guide to Clinical Trials written by Allan Hackshaw and published by John Wiley & Sons. This book was released on 2011-09-07 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies