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Clinical research and the law / (Record no. 11844)

000 -LEADER
fixed length control field 06075cam a2200721Mi 4500
001 - CONTROL NUMBER
control field ocn785811678
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20171224113928.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr |n|---|||||
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 120416s2012 nju ob 001 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency EBLCP
Language of cataloging eng
Description conventions pn
Transcribing agency EBLCP
Modifying agency OCLCQ
-- N$T
-- OCLCQ
-- YDXCP
-- OCLCO
-- CUS
-- DG1
-- OCLCQ
-- OHI
-- OCLCF
-- OCLCQ
-- DEBSZ
-- OCLCQ
-- COO
-- OCLCQ
-- DEBBG
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118272152
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1118272153
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118272183
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1118272188
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781405195676
Qualifying information (paper)
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 431125694
029 1# - (OCLC)
OCLC library identifier NZ1
System control number 15900629
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043394464
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)785811678
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number R724
072 #7 - SUBJECT CATEGORY CODE
Subject category code LAW
Subject category code subdivision 046000
Source bisacsh
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 344.04
-- 344.04/196
049 ## - LOCAL HOLDINGS (OCLC)
Holding library MAIN
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Tereskerz, Patricia M.
245 10 - TITLE STATEMENT
Title Clinical research and the law /
Statement of responsibility, etc Patricia M. Tereskerz.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Hoboken :
Name of publisher, distributor, etc John Wiley & Sons,
Date of publication, distribution, etc 2012.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (282 pages)
336 ## -
-- text
-- txt
-- rdacontent
337 ## -
-- computer
-- c
-- rdamedia
338 ## -
-- online resource
-- cr
-- rdacarrier
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Clinical Research and the Law; Contents; Preface; Chapter 1: Research malpractice and negligence; 1.1 Background; 1.2 Drugs: brief description of definitions; 1.3 Brief overview: conduct of clinical trials; 1.4 Medical devices; 1.5 Research malpractice: the basics; 1.6 Negligence actions and research: interesting aspects of medical research negligence cases; Chapter 2: Duty of care: understanding the legal differences between medical treatment and medical research; 2.1 Establishing duty of care; 2.2 Do sponsors have a legal duty?
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Chapter 3: Establishing standard of care and violation of standard of care; 3.1 Research malpractice and using expert testimony to establish the standard of care; 3.2 Lessons learned from surgical innovation cases; 3.3 Standard of care and informed consent cases; Chapter 4: Informed consent in clinical research; 4.1 Basics on informed consent in the clinical treatment setting: background; 4.2 Informed consent as applied to the research setting; 4.3 Informed consent and federal regulations; 4.4 Case law and federal regulations; 4.5 Clinical trials and pediatric patients.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs); 5.1 Liability for negligence; 5.2 Standard of care; 5.3 Proximate cause and damages; 5.4 Defense; 5.5 Practical considerations: the need for indemnification; 5.6 Special considerations for DSMBs; Chapter 6: Legal aspects of financial conflicts of interest in clinical trials; 6.1 Overview; 6.2 Legislative background: road to creating financial conflicts of interest; 6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 6.4 Regulations/legislation; 6.5 Litigation involving financial conflicts of interest in clinical trials; 6.6 Applying novel legal theories to financial conflicts of interest cases; 6.7 Other clinical trial cases involving financial conflicts of interest claiming constitutional violations; Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results; 7.1 GlaxoSmithKline; 7.2 Vioxx and Merck; 7.3 Government and other clinical trial disclosure requirements; 7.4 Medical journal editors and disclosure of clinical trial information.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Chapter 8: Clinical trials and insider trading; 8.1 Purpose of insider trading laws; 8.2 Proving insider trading; 8.3 Penalties; 8.4 Insider trading cases and clinical trials; 8.5 Beware: investigators and relationships with the investment industry--a risk of recent vintage; 8.6 Setting the stage; Chapter 9: Clinical trials and criminal law; 9.1 How clinical trial investigators have been implicated in criminal acts; 9.2 False Claims Act cases and health-care fraud; 9.3 Clinical trial False Claims Act cases; 9.4 Enforcement of the False Claims Act against institutions; 9.5 Anti-kickback law.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 9.6 Health-care fraud.
520 ## - SUMMARY, ETC.
Summary, etc 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.
588 0# -
-- Print version record.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical medicine
General subdivision Research.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials
General subdivision Law and legislation.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Biomedical Research
General subdivision legislation & jurisprudence
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Biomedical Research
General subdivision legislation & jurisprudence.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Biomedical Research
General subdivision standards
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical Trials as Topic
General subdivision legislation & jurisprudence
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical Trials as Topic
General subdivision standards
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Law.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element LAW
General subdivision Health.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical medicine
General subdivision Research.
Source of heading or term fast
-- (OCoLC)fst00864379
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials
General subdivision Law and legislation.
Source of heading or term fast
-- (OCoLC)fst00864434
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Print version:
Main entry heading Tereskerz, Patricia M.
Title Clinical Research and the Law.
Place, publisher, and date of publication Hoboken : John Wiley & Sons, ©2012
International Standard Book Number 9781405195676
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://onlinelibrary.wiley.com/book/10.1002/9781118272152
Public note Wiley Online Library
938 ## -
-- EBL - Ebook Library
-- EBLB
-- EBL887937
938 ## -
-- EBSCOhost
-- EBSC
-- 446162
938 ## -
-- YBP Library Services
-- YANK
-- 7586958
938 ## -
-- YBP Library Services
-- YANK
-- 12671666
994 ## -
-- 92
-- DG1

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