Clinical Research Compliance Manual
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Author |
: Patricia L. Brent |
Publisher |
: Aspen Publishers |
Total Pages |
: 0 |
Release |
: 2007 |
ISBN-10 |
: 0735569665 |
ISBN-13 |
: 9780735569669 |
Rating |
: 4/5 (65 Downloads) |
Synopsis Clinical Research Compliance Manual by : Patricia L. Brent
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 |
: Lawrence W. Vernaglia |
Publisher |
: Aspen Publishers |
Total Pages |
: 776 |
Release |
: 2019-11-17 |
ISBN-10 |
: 1543817556 |
ISBN-13 |
: 9781543817553 |
Rating |
: 4/5 (56 Downloads) |
Synopsis Clinical Research Compliance Manual by : Lawrence W. Vernaglia
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 |
: Lawrence W. Vernaglia |
Publisher |
: Aspen Publishers |
Total Pages |
: 792 |
Release |
: 2020-10-21 |
ISBN-10 |
: 1543832008 |
ISBN-13 |
: 9781543832006 |
Rating |
: 4/5 (08 Downloads) |
Synopsis Clinical Research Compliance Manual by : Lawrence W. Vernaglia
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 |
: Lawrence W. Vernaglia |
Publisher |
: |
Total Pages |
: |
Release |
: 2019 |
ISBN-10 |
: 1543806724 |
ISBN-13 |
: 9781543806724 |
Rating |
: 4/5 (24 Downloads) |
Synopsis Clinical Research Compliance Manual by : Lawrence W. Vernaglia
Author |
: Aspen Publishers |
Publisher |
: Aspen Publishers |
Total Pages |
: |
Release |
: 2006 |
ISBN-10 |
: 0735562342 |
ISBN-13 |
: 9780735562349 |
Rating |
: 4/5 (42 Downloads) |
Synopsis Clinical Research Compliance Manual by : Aspen Publishers
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 |
: John E. Steiner |
Publisher |
: Jones & Bartlett Learning |
Total Pages |
: 498 |
Release |
: 2006 |
ISBN-10 |
: 0763747254 |
ISBN-13 |
: 9780763747251 |
Rating |
: 4/5 (54 Downloads) |
Synopsis Clinical Research Law and Compliance Handbook by : John E. Steiner
Law/Ethics
Author |
: Health Care Compliance Association |
Publisher |
: |
Total Pages |
: |
Release |
: 2019-03 |
ISBN-10 |
: 1733598618 |
ISBN-13 |
: 9781733598613 |
Rating |
: 4/5 (18 Downloads) |
Synopsis Research Compliance Professional's Handbook, 3rd Edition by : Health Care Compliance Association
Author |
: |
Publisher |
: |
Total Pages |
: |
Release |
: 2021-04 |
ISBN-10 |
: 1733598758 |
ISBN-13 |
: 9781733598750 |
Rating |
: 4/5 (58 Downloads) |
Synopsis Complete Healthcare Compliance Manual 2021 by :
Author |
: Graham Ogg |
Publisher |
: CRC Press |
Total Pages |
: 229 |
Release |
: 2005-11-01 |
ISBN-10 |
: 9781040061633 |
ISBN-13 |
: 104006163X |
Rating |
: 4/5 (33 Downloads) |
Synopsis A Practical Guide to Quality Management in Clinical Trial Research by : Graham Ogg
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
Author |
: Fay A. Rozovsky |
Publisher |
: Jossey-Bass |
Total Pages |
: 0 |
Release |
: 2003-06-10 |
ISBN-10 |
: 0787965707 |
ISBN-13 |
: 9780787965709 |
Rating |
: 4/5 (07 Downloads) |
Synopsis Clinical Trials and Human Research by : Fay A. Rozovsky
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.