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Principles and practice of clinical ...

Gallin, John I.

Principles and practice of clinical research

Record Type:	Electronic resources : Monograph/item
Title/Author:	Principles and practice of clinical research[edited by] John I. Gallin, Frederick P. Ognibene.
other author:	Gallin, John I.
Published:	Amsterdam ;Elsevier/Academic Press,c2007.
Description:	xvi, 430 p. :ill. ;29 cm.
Notes:	Prev. ed. cataloged as: Principles and practice of clinical research / John I. Gallin.
Subject:	Clinical medicineResearch.
Online resource:	An electronic book accessible through the World Wide Web; click for information
Online resource:	http://www.engineeringvillage.com/controller/servlet/OpenURL?genre=book&isbn=9780123694409
Online resource:	http://www.loc.gov/catdir/toc/ecip0710/2007004577.html
Online resource:	http://www.loc.gov/catdir/enhancements/fy0708/2007004577-d.html
ISBN:	9780123694409

Principles and practice of clinical research
Principles and practice of clinical research[electronic resource] /[edited by] John I. Gallin, Frederick P. Ognibene. - 2nd ed. - Amsterdam ;Elsevier/Academic Press,c2007. - xvi, 430 p. :ill. ;29 cm.

Prev. ed. cataloged as: Principles and practice of clinical research / John I. Gallin.

Includes bibliographical references and index.

A Historical Perspective on Clinical Research -- ETHICAL, REGULATORY, AND LEGAL ISSUES -- Ethical Principles in Clinical Research -- Researching a Bioethical Question -- Integrity in Research: Individual and Institutional Responsibility -- Institutional Review Boards -- Data and Safety Monitoring Boards -- Data Management in Clinical Trials -- Unanticipated Risks in Clinical Research -- The Regulation of Drugs and Biological Products by the Food and Drug Administration -- Legal Issues -- Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research -- National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research -- Clinical Research: A Patient Perspective -- The Clinical Researcher and the Media -- BIOSTATISTICS AND EPIDEMIOLOGY -- An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation -- Design and Conduct of Observational Studies and Clinical Trials -- Small Clinical Trials -- Large Clinical Trials and Registries - Clinical Research Institutes -- Using Secondary Data in Statistical Analysis -- An Introduction to Survival Analysis -- Measures of Function and Health-Related Quality of Life -- TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES -- Overview of Technology Development -- Technology Transfer -- Writing a Protocol -- Evaluating a Protocol Budget -- Data Management in Clinical Research: General Principles and a Guide to Sources -- Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process -- Clinical Research from the Industry Perspective -- Human Genome Project, Genomics, and Clinical Research.

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government.

Electronic reproduction.
Amsterdam :
Elsevier Science & Technology,
2007.

Mode of access: World Wide Web.

ISBN: 9780123694409

Source: 113418:113508Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

280808
Clinical medicine
--Research.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: R850 / .G35 2007eb

Dewey Class. No.: 616.0072

National Library of Medicine Call No.: 2007 G-705

Principles and practice of clinical research
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245 0 0 $a Principles and practice of clinical research $h [electronic resource] / $c [edited by] John I. Gallin, Frederick P. Ognibene.
250 $a 2nd ed.
260 $a Amsterdam ; $a Boston : $c c2007. $b Elsevier/Academic Press,
300 $a xvi, 430 p. : $b ill. ; $c 29 cm.
500 $a Prev. ed. cataloged as: Principles and practice of clinical research / John I. Gallin.
504 $a Includes bibliographical references and index.
505 0 $a A Historical Perspective on Clinical Research -- ETHICAL, REGULATORY, AND LEGAL ISSUES -- Ethical Principles in Clinical Research -- Researching a Bioethical Question -- Integrity in Research: Individual and Institutional Responsibility -- Institutional Review Boards -- Data and Safety Monitoring Boards -- Data Management in Clinical Trials -- Unanticipated Risks in Clinical Research -- The Regulation of Drugs and Biological Products by the Food and Drug Administration -- Legal Issues -- Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research -- National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research -- Clinical Research: A Patient Perspective -- The Clinical Researcher and the Media -- BIOSTATISTICS AND EPIDEMIOLOGY -- An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation -- Design and Conduct of Observational Studies and Clinical Trials -- Small Clinical Trials -- Large Clinical Trials and Registries - Clinical Research Institutes -- Using Secondary Data in Statistical Analysis -- An Introduction to Survival Analysis -- Measures of Function and Health-Related Quality of Life -- TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES -- Overview of Technology Development -- Technology Transfer -- Writing a Protocol -- Evaluating a Protocol Budget -- Data Management in Clinical Research: General Principles and a Guide to Sources -- Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process -- Clinical Research from the Industry Perspective -- Human Genome Project, Genomics, and Clinical Research.
520 $a The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government.
533 $a Electronic reproduction. $b Amsterdam : $c Elsevier Science & Technology, $d 2007. $n Mode of access: World Wide Web. $n System requirements: Web browser. $n Title from title screen (viewed on Aug. 2, 2007). $n Access may be restricted to users at subscribing institutions.
650 0 $a Clinical medicine $x Research. $3 280808
650 1 2 $a Research $x methods. $3 216992
650 6 $a M�edecine clinique $x Recherche. $3 340937
655 7 $a Electronic books. $2 local. $3 214472
700 1 $a Gallin, John I. $3 340934
700 1 $a Ognibene, Frederick P. $3 340935
710 2 $a ScienceDirect (Online service) $3 307425
856 4 0 $3 ScienceDirect $u http://www.sciencedirect.com/science/book/9780123694409 $z An electronic book accessible through the World Wide Web; click for information
856 4 0 $3 Referex $u http://www.engineeringvillage.com/controller/servlet/OpenURL?genre=book&isbn=9780123694409 $z An electronic book accessible through the World Wide Web; click for information
856 4 1 $3 Table of contents only $u http://www.loc.gov/catdir/toc/ecip0710/2007004577.html
856 4 2 $3 Publisher description $u http://www.loc.gov/catdir/enhancements/fy0708/2007004577-d.html
994 $a C0 $b TEF

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http://www.sciencedirect.com/science/book/9780123694409
http://www.engineeringvillage.com/controller/servlet/OpenURL?genre=book&isbn=9780123694409
http://www.loc.gov/catdir/toc/ecip0710/2007004577.html
http://www.loc.gov/catdir/enhancements/fy0708/2007004577-d.html

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