عنوان
پدید آورنده
موضوع
رده
R853.C55 L58 2010
R853
.
C55
L58
2010
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
1405195150
(Number (ISBN
9781405195157
NATIONAL BIBLIOGRAPHY NUMBER
Number
dltt
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
A clinical trials manual from the Duke Clinical Research Institute :
General Material Designation
[Book]
Other Title Information
lessons from a horse named Jim /
First Statement of Responsibility
Margaret B. Liu and Kate Davis
EDITION STATEMENT
Edition Statement
2nd ed
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Hoboken, NJ :
Name of Publisher, Distributor, etc.
Wiley-Blackwell,
Date of Publication, Distribution, etc.
2010
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xviii, 406 p. :
Other Physical Details
ill. ;
Dimensions
25 cm
GENERAL NOTES
Text of Note
Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index
CONTENTS NOTE
Text of Note
Lessons from a horse named Jim and other events in history affecting the regulation of clinical research -- The process : developing new drugs, biologics, and devices -- Good clinical practice and the regulations -- Informed consent and the regulations -- Institutional review boards -- Adverse events and unanticipated problems involving risks to subjects and others -- Monitoring, audits, and inspections -- The principal investigator, the clinical research coordinator, and the study site -- The protocol -- Study feasibility : reviewing a specific protocol -- Study activities -- Study documents/essential documents -- Management of study drugs, biologics, and devices -- Managing clinical trial data -- Global health and international trials
0
TOPICAL NAME USED AS SUBJECT
Clinical trials, Handbooks, manuals, etc
Drugs-- Testing, Handbooks, manuals, etc
Clinical Trials as Topic-- ethics-- United States
Clinical Trials as Topic-- legislation & jurisprudence-- United States
Device Approval-- United States
Drug Approval-- United States
DEWEY DECIMAL CLASSIFICATION
Number
615
.
5072/4
Edition
22
LIBRARY OF CONGRESS CLASSIFICATION
Class number
R853
.
C55
Book number
L58
2010
OTHER CLASS NUMBERS
Class number
2010
B-988
Class number
QV
733
AA1
Book Number
L783c
2010
PERSONAL NAME - PRIMARY RESPONSIBILITY
Liu, Margaret B
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Davis, Kate, (Kate G.)
Liu, Margaret B.
CORPORATE BODY NAME - ALTERNATIVE RESPONSIBILITY
Duke Clinical Research Institute
ORIGINATING SOURCE
Date of Transaction
20100507030700.0
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
