عنوان
پدید آورنده
موضوع
رده
R853.C55 C585 2004eb
R853
.
C55
C585
2004eb
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
0203492064
(Number (ISBN
0849321816
(Number (ISBN
9780203492062
(Number (ISBN
9780849321818
Erroneous ISBN
0849321816
NATIONAL BIBLIOGRAPHY NUMBER
Number
b706953
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Handbook of SOPs for good clinical practice /
General Material Designation
[Book]
First Statement of Responsibility
Celine Clive.
EDITION STATEMENT
Edition Statement
2nd ed.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Boca Raton :
Name of Publisher, Distributor, etc.
Interpharm/CRC Press,
Date of Publication, Distribution, etc.
©2004.
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
1 online resource (270 pages) :
Other Physical Details
illustrations
GENERAL NOTES
Text of Note
Revised edition of: A handbook of SOPs for good clinical practice / Donald E. Maynard, B. Joyce Baird. c1996.
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index.
CONTENTS NOTE
Text of Note
Front Cover; Table of Contents; MON-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs); MON-002.0: Training Clinical Research Staff; MON-003.0: Selecting Investigators and Study Sites; MON-004.0: Developing Informed Consent Forms; MON-005.0: Conducting Site Evaluation Visits; MON-006.0: Conducting Study Initiation Visits; MON-007.0: Conducting Periodic Site Visits; MON-008.0: Reviewing Case Report Forms at the Study Site; MON-009.0: Reviewing Regulatory Documents; MON-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs), and IND Safety Reports.
0
SUMMARY OR ABSTRACT
Text of Note
Completely revised and updated, this second edition of a classic handbook provides templates of SOPs ready for immediate adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that readers can easily modify the text to reflect their organization's processes. The language ranges from the specific to the very general, depending on the activity described and the number of the existing regulations governing it. The handboo.
ACQUISITION INFORMATION NOTE
Source for Acquisition/Subscription Address
Ingram Content Group
Stock Number
TANDF_194869
OTHER EDITION IN ANOTHER MEDIUM
Title
Handbook of SOPs for good clinical practice.
International Standard Book Number
0849321816
PARALLEL TITLE PROPER
Parallel Title
Handbook of standard operating procedures for good clinical practice
TOPICAL NAME USED AS SUBJECT
Clinical trials-- Standards, Handbooks, manuals, etc.
Clinical trials, Forms, Handbooks, manuals, etc.
Clinical Trials-- standards.
Human Experimentation-- standards.
Legislation, Drug.
Research-- standards.
Clinical trials-- Standards.
Clinical trials.
MEDICAL-- Laboratory Medicine.
(SUBJECT CATEGORY (Provisional
MED-- 047000
DEWEY DECIMAL CLASSIFICATION
Number
610/
.
72/4
Edition
22
LIBRARY OF CONGRESS CLASSIFICATION
Class number
R853
.
C55
Book number
C585
2004eb
OTHER CLASS NUMBERS
Class number
2004
E-403
Class number
W
49
Book Number
C642h
2004
PERSONAL NAME - PRIMARY RESPONSIBILITY
Clive, Celine.
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Maynard, Donald E.
ORIGINATING SOURCE
Date of Transaction
20201207220733.0
Cataloguing Rules (Descriptive Conventions))
pn
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
