Download Clinical Research Law And Compliance Handbook full books in PDF, epub, and Kindle. Read online Clinical Research Law And Compliance Handbook ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author : John E. Steiner
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780763747251
Total Pages : 498 pages
Book Rating : 4.54/5 ( download)
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
Author : Lawrence W. Vernaglia
Publisher : Aspen Publishers
ISBN 13 : 9781543832006
Total Pages : 792 pages
Book Rating : 4.08/5 ( download)
Download or read book Clinical Research Compliance Manual written by Lawrence W. Vernaglia and published by Aspen Publishers. This book was released on 2020-10-21 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: For 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 : Patricia L. Brent
Publisher : Aspen Publishers
ISBN 13 : 9780735569669
Total Pages : 0 pages
Book Rating : 4.65/5 ( download)
Download or read book Clinical Research Compliance Manual written by Patricia L. Brent and published by Aspen Publishers. This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For 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
ISBN 13 : 1405195673
Total Pages : 295 pages
Book Rating : 4.76/5 ( download)
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.
Author : Lawrence W. Vernaglia
Publisher : Aspen Publishers
ISBN 13 : 9781543817553
Total Pages : 776 pages
Book Rating : 4.56/5 ( download)
Download or read book Clinical Research Compliance Manual written by Lawrence W. Vernaglia and published by Aspen Publishers. This book was released on 2019-11-17 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: For 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 : Fay A. Rozovsky
Publisher : Jossey-Bass
ISBN 13 : 9780787965709
Total Pages : 0 pages
Book Rating : 4.07/5 ( download)
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.
Author : Carmen Medina
Publisher : CRC Press
ISBN 13 : 1135520461
Total Pages : 604 pages
Book Rating : 4.65/5 ( download)
Download or read book Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Author : Lawrence W. Vernaglia
Publisher :
ISBN 13 : 9781543806724
Total Pages : pages
Book Rating : 4.24/5 ( download)
Download or read book Clinical Research Compliance Manual written by Lawrence W. Vernaglia and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Aspen Publishers
Publisher : Aspen Publishers
ISBN 13 : 9780735562349
Total Pages : pages
Book Rating : 4.42/5 ( download)
Download or read book Clinical Research Compliance Manual written by Aspen Publishers and published by Aspen Publishers. This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: For 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 :
ISBN 13 : 9781522178026
Total Pages : 319 pages
Book Rating : 4.23/5 ( download)
Download or read book Pharmaceutical and Medical Device Compliance Manual written by Ela Bochenek and published by . This book was released on 2019 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 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
