Research Compliance Professional's Handbook, 3rd Edition
| Author | : Health Care Compliance Association |
| Publisher | : |
| Total Pages | : |
| Release | : 2019-03 |
| Genre | : |
| ISBN | : 9781733598613 |
Clinical Research Compliance Manual
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A Practical Guide to Managing Clinical Trials
| Author | : JoAnn Pfeiffer |
| Publisher | : CRC Press |
| Total Pages | : 292 |
| Release | : 2017-05-18 |
| Genre | : Mathematics |
| ISBN | : 1315299771 |
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
AHLA Health Care Compliance Legal Issues Manual (Non-members)
| Author | : American Health Lawyers Association |
| Publisher | : |
| Total Pages | : |
| Release | : 2019 |
| Genre | : |
| ISBN | : 9781522173441 |
Authored by experts with years of health care compliance experience, this new edition integrates changes in regulation, trends in enforcement, and the reasoning of the courts to help you navigate emerging and unsettled areas of compliance risk, such as self-disclosure obligations, risks associated with opioid use, and the impact of statistical sampling.Highlights of this edition include:All new glossary of health care compliance terms, including key statutes, acronyms, governing agencies, and moreExpanded civil monetary penalty and exclusion authorities under 2017 final rulesDiscussion of core elements of compliance programs for Medicare Advantage Plans and Part D Plans as established by federal regulationsExpanded whistleblower protections under federal and state law, false claims based on lack of medical necessity, materiality after Escobar, and recent enforcement activityExpanded discussion of determinations of medical necessity, CMS review of medical necessity terminations, consequences, and appeals processesRecent health information privacy and security developments, including new guidance, risks associated with innovative technologies, and trends in Health Insurance Portability and Accountability Act (HIPAA) enforcement activityNew chapters:Chapter 1, Glossary of Key TermsChapter 10, The Relationship between Enforcement and ComplianceChapter 17, Health Care Civil Rights and Nondiscrimination Under Section 1557 of the Affordable Care ActChapter 19, Behavioral Health
Clinical Trials Audit Preparation
| Author | : Vera Mihajlovic-Madzarevic |
| Publisher | : John Wiley & Sons |
| Total Pages | : 186 |
| Release | : 2010-09-29 |
| Genre | : Medical |
| ISBN | : 0470920882 |
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
The Health Care Compliance Professional's Manual
| Author | : Hcca |
| Publisher | : Aspen Publishers |
| Total Pages | : 1080 |
| Release | : 2007 |
| Genre | : Law |
| ISBN | : 9780735570382 |
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
The Sourcebook for Clinical Research
| Author | : Natasha Martien |
| Publisher | : Academic Press |
| Total Pages | : 278 |
| Release | : 2018-08-01 |
| Genre | : Medical |
| ISBN | : 0128162430 |
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
FDA Investigations Operations Manual
| Author | : Food and Drug Administration |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2003 |
| Genre | : Drugs |
| ISBN | : 9780865879737 |
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Manual of Clinical Oncology
| Author | : Bartosz Chmielowski |
| Publisher | : Lippincott Williams & Wilkins |
| Total Pages | : 1151 |
| Release | : 2017-02-23 |
| Genre | : Medical |
| ISBN | : 1496349598 |
Concise, portable, and packed with essential information, Manual of Clinical Oncology is an indispensable resource for understanding basic science, clinical findings, and available technology as they relate to the diagnosis and management patients with cancer. The practical format provides high-yield content useful for participating in rounds ad making diagnostic and therapeutic decisions at the bedside. Edited by Dr. Bartosz Chmielowski and Dr. Mary Territo, both from UCLA School of Medicine, this eighth edition carries on the tradition of excellence set forth by longtime editor Dr. Dennis Casciato. Incorporates recent major achievements in immunotherapies, biologics, and targeted therapies. Features new chapters on the biology of cancer, immunotherapy, and cancer survivorship. Contains numerous diagnostic and treatment algorithms, as well as content on complications, for assistance with clinical decision making. Includes helpful appendices such as a glossary of cytogenetic nomenclature and combination chemotherapy regimens. Your book purchase includes a complimentary download of the enhanced eBook for iOS, Android, PC & Mac. Take advantage of these practical features that will improve your eBook experience: The ability to download the eBook on multiple devices at one time — providing a seamless reading experience online or offline Powerful search tools and smart navigation cross-links that allow you to search within this book, or across your entire library of VitalSource eBooks Multiple viewing options that enable you to scale images and text to any size without losing page clarity as well as responsive design The ability to highlight text and add notes with one click
Registries for Evaluating Patient Outcomes
| Author | : Agency for Healthcare Research and Quality/AHRQ |
| Publisher | : Government Printing Office |
| Total Pages | : 385 |
| Release | : 2014-04-01 |
| Genre | : Medical |
| ISBN | : 1587634333 |
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
