Quick Guide to Good Clinical Practice (Post nr. 6808)

MARC-detaljer
000 -LEADER
fixed length control field	03713nam a22004935i 4500
001 - CONTROL NUMBER
control field	60184
005 - DATE AND TIME OF LATEST TRANSACTION
control field	20200226102542.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field	cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field	161115s2017 gw \| s \|\|\|\| 0\|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number	9783319443447
--	978-3-319-44344-7
024 7# - OTHER STANDARD IDENTIFIER
Standard number or code	10.1007/978-3-319-44344-7
Source of number or code	doi
035 ## - SYSTEM CONTROL NUMBER
System control number	(DE-He213)978-3-319-44344-7
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number	RS1-441
072 #7 - SUBJECT CATEGORY CODE
Subject category code	MMG
Source	bicssc
072 #7 - SUBJECT CATEGORY CODE
Subject category code	MED071000
Source	bisacsh
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number	353.998
Edition number	23
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name	Cingi, Cemal.
Relator term	author.
245 10 - TITLE STATEMENT
Title	Quick Guide to Good Clinical Practice
Medium	[electronic resource] :
Remainder of title	How to Meet International Quality Standard in Clinical Research /
Statement of responsibility, etc.	by Cemal Cingi, Nuray Bayar Muluk.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture	Cham :
Name of producer, publisher, distributor, manufacturer	Springer International Publishing :
--	Imprint: Springer,
Date of production, publication, distribution, manufacture, or copyright notice	2017.
300 ## - PHYSICAL DESCRIPTION
Extent	XVIII, 237 p.
Other physical details	online resource.
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
347 ## - DIGITAL FILE CHARACTERISTICS
File type	text file
Encoding format	PDF
Source	rda
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note	1 Clinical Trials: Historical Aspects and Importance and New Drug Developments -- 2 The Definition of GCP -- 3 The Principles of GCP -- 4 The Drug Development Process and Evolution of Regulations -- 5 Planning Clinical Research -- 6 Preparation of Ethics Committee (IRB) Proposal -- 7 Preparation of Informed Consent -- 8 Preparation of Findings Tables -- 9 Setting the Ideal Statistical Methods -- 10 The Duties of a Clinical Research Coordinator -- 11 The Duties of Clinical Researchers -- 12 The Phases of Clinical Studies -- 13 Safety in Clinical Trials -- 14 Setting the Size -- 15 Setting the Ideal Method -- 16 Ethics of Clinical Research -- 17 Recruitment and Enrolment -- 18 Why we need Clinical Consent and Other Documentation -- 19 Monitoring the Trial -- 20 Inspection -- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC) -- 22 Responsibilities of the Investigator -- 23 Responsibilities of the Sponsor -- 24.Clinical Trial Protocols.
520 ## - SUMMARY, ETC.
Summary, etc.	This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Medicine.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Surgery.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Pharmacy.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Medical education.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Statistics.
650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Medicine & Public Health.
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Drug Safety and Pharmacovigilance.
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Statistics for Life Sciences, Medicine, Health Sciences.
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	General Surgery.
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Medical education.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name	Bayar Muluk, Nuray.
Relator term	author.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element	SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title	Springer eBooks
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information	Printed edition:
International Standard Book Number	9783319443430
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier	<a href="http://dx.doi.org/10.1007/978-3-319-44344-7">http://dx.doi.org/10.1007/978-3-319-44344-7</a>
912 ## -
--	ZDB-2-SME

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