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Guide for investigator initiated trials

Fortwengel, Gerhard.

Guide for investigator initiated trials

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Guide for investigator initiated trialsGerhard Fortwengel.
作者:	Fortwengel, Gerhard.
出版者:	Basel :Karger,c2011.
面頁冊數:	1 online resource.
標題:	Clinical trials.
電子資源:	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:

181901
Clinical trials.
Index Terms--Genre/Form:

214472
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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245 1 0 $a Guide for investigator initiated trials $h [electronic resource] / $c Gerhard Fortwengel.
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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 181901
650 1 2 $a Clinical Trials as Topic. $3 265581
650 2 2 $a Research Design. $3 219042
655 4 $a Electronic books. $2 local. $3 214472
856 4 0 $u http://www.karger.com/Book/Home/254780