Clinical research and the law / (Record no. 63325)
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| 000 -LEADER | |
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| fixed length control field | 06123cam a2200721Mi 4500 |
| 001 - CONTROL NUMBER | |
| control field | sulb-eb0031673 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-SySUS |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20170713221306.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| 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 |
| -- | BD-SySUS |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118272152 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 1118272153 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 9781118272183 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 1118272188 |
| Qualifying information | (electronic bk.) |
| Canceled/invalid ISBN | 9781405195676 |
| Qualifying information | (paper) |
| 029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
| OCLC library identifier | DEBSZ |
| System control number | 431125694 |
| OCLC library identifier | NZ1 |
| System control number | 15900629 |
| 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 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | 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? |
| 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. |
| 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. |
| 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. |
| 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. |
| 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# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | 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. |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Law and legislation. |
| Topical term or geographic name as entry element | Biomedical Research |
| General subdivision | legislation & jurisprudence |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | Biomedical Research |
| General subdivision | legislation & jurisprudence. |
| Topical term or geographic name as entry element | Biomedical Research |
| General subdivision | standards |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | Clinical Trials as Topic |
| General subdivision | legislation & jurisprudence |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | Clinical Trials as Topic |
| General subdivision | standards |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | Medicine. |
| Topical term or geographic name as entry element | Law. |
| Topical term or geographic name as entry element | LAW |
| General subdivision | Health. |
| Source of heading or term | bisacsh |
| Topical term or geographic name as entry element | Clinical medicine |
| General subdivision | Research. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00864379 |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Law and legislation. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00864434 |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | 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 | <a href="http://onlinelibrary.wiley.com/book/10.1002/9781118272152">http://onlinelibrary.wiley.com/book/10.1002/9781118272152</a> |
| Public note | Wiley Online Library [Free Download only for SUST IP] |
| 938 ## - | |
| -- | EBL - Ebook Library |
| -- | EBLB |
| -- | EBL887937 |
| -- | EBSCOhost |
| -- | EBSC |
| -- | 446162 |
| -- | YBP Library Services |
| -- | YANK |
| -- | 7586958 |
| -- | YBP Library Services |
| -- | YANK |
| -- | 12671666 |
| 994 ## - | |
| -- | 92 |
| -- | DG1 |
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