Clinical Research Law and Compliance Handbook
Author: John E. Steiner
Publisher: Jones & Bartlett Learning
Published: 2006
Total Pages: 498
ISBN-13: 9780763747251
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Author: John E. Steiner
Publisher: Jones & Bartlett Learning
Published: 2006
Total Pages: 498
ISBN-13: 9780763747251
DOWNLOAD EBOOKLaw/Ethics
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.
Author: Lawrence W. Vernaglia
Publisher: Aspen Publishers
Published: 2020-10-21
Total Pages: 792
ISBN-13: 9781543832006
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!
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
Author: Patricia L. Brent
Publisher: Aspen Publishers
Published: 2007
Total Pages: 0
ISBN-13: 9780735569669
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, 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!
Author: Patricia M. Tereskerz
Publisher: John Wiley & Sons
Published: 2012-05-07
Total Pages: 295
ISBN-13: 1405195673
DOWNLOAD EBOOKThis 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.
Author: P. Michael Dubinsky
Publisher: John Wiley & Sons
Published: 2022-01-26
Total Pages: 554
ISBN-13: 1118949595
DOWNLOAD EBOOKThis 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
Author: Aspen Publishers
Publisher: Aspen Publishers
Published: 2006
Total Pages:
ISBN-13: 9780735562349
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. In addition, it: 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.
Author: Ela Bochenek
Publisher:
Published: 2019
Total Pages: 319
ISBN-13: 9781522178026
DOWNLOAD EBOOKA robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry
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