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Guide for investigator initiated trials

Fortwengel, Gerhard.

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Guide for investigator initiated trials

Record Type:	Electronic resources : Monograph/item
Title/Author:	Guide for investigator initiated trials/ Gerhard Fortwengel.
Author:	Fortwengel, Gerhard.
Published:	Basel :Karger, : c2011.,
Description:	1 online resource.
[NT 15003449]:	Risk-benefit analysis -- Study types and study design -- Investigational medicinal products -- Study protocol -- Case report forms -- Financing -- Qualifications, CVS of site staff, training, delegation of authority -- EudraCT -- Contracts -- Informed consent -- Investigator's brochure/summary of product characteristics -- Insurance -- Health authority approval -- Ethics -- Trial master file, updating and archiving -- Documentation -- Data management -- Screening -- Pharmacovigilance -- Patient compliance -- Source data verification -- Quality -- Monitoring -- Biometry -- Multicentre trials -- Final study report and publication.
Subject:	Clinical trials. -
Online resource:	http://www.karger.com/Book/Home/254780
ISBN:	9783805596855 (electronic bk.)

Guide for investigator initiated trials
Fortwengel, Gerhard.

Guide for investigator initiated trials[electronic resource] /Gerhard Fortwengel. - Basel :Karger,c2011. - 1 online resource.

Includes bibliographical references and index.

Risk-benefit analysis -- Study types and study design -- Investigational medicinal products -- Study protocol -- Case report forms -- Financing -- Qualifications, CVS of site staff, training, delegation of authority -- EudraCT -- Contracts -- Informed consent -- Investigator's brochure/summary of product characteristics -- Insurance -- Health authority approval -- Ethics -- Trial master file, updating and archiving -- Documentation -- Data management -- Screening -- Pharmacovigilance -- Patient compliance -- Source data verification -- Quality -- Monitoring -- Biometry -- Multicentre trials -- Final study report and publication.

ISBN: 9783805596855 (electronic bk.)Subjects--Topical Terms:

724498
Clinical trials.
Index Terms--Genre/Form:

542853
Electronic books.

LC Class. No.: R853.C55 / F672 2011

Dewey Class. No.: 615.5072/4

National Library of Medicine Call No.: W 20.5

Guide for investigator initiated trials
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020 $a 3805596855 (electronic bk.)
020 $z 9783805596848
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100 1 $a Fortwengel, Gerhard. $3 2016779
245 1 0 $a Guide for investigator initiated trials $h [electronic resource] / $c Gerhard Fortwengel.
260 $a Basel : $b Karger, $c c2011.
300 $a 1 online resource.
504 $a Includes bibliographical references and index.
505 0 $a Risk-benefit analysis -- Study types and study design -- Investigational medicinal products -- Study protocol -- Case report forms -- Financing -- Qualifications, CVS of site staff, training, delegation of authority -- EudraCT -- Contracts -- Informed consent -- Investigator's brochure/summary of product characteristics -- Insurance -- Health authority approval -- Ethics -- Trial master file, updating and archiving -- Documentation -- Data management -- Screening -- Pharmacovigilance -- Patient compliance -- Source data verification -- Quality -- Monitoring -- Biometry -- Multicentre trials -- Final study report and publication.
588 $a Description based on print version record.
650 0 $a Clinical trials. $3 724498
650 1 2 $a Clinical Trials as Topic. $3 1074953
650 2 2 $a Research Design. $3 709476
655 4 $a Electronic books. $2 lcsh $3 542853
856 4 0 $u http://www.karger.com/Book/Home/254780