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Guide for investigator initiated tri...
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Fortwengel, Gerhard.
Guide for investigator initiated trials[electronic resource] /
紀錄類型:
書目-語言資料,印刷品 : Monograph/item
杜威分類號:
615.5072/4
書名/作者:
Guide for investigator initiated trials/ Gerhard Fortwengel.
作者:
Fortwengel, Gerhard.
出版者:
Basel : : Karger,, c2011.
面頁冊數:
1 online resource.
標題:
Clinical trials.
標題:
Clinical Trials as Topic.
標題:
Research Design.
ISBN:
9783805596855 (electronic bk.)
ISBN:
3805596855 (electronic bk.)
書目註:
Includes bibliographical references and index.
內容註:
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.
電子資源:
http://www.karger.com/Book/Home/254780
Guide for investigator initiated trials[electronic resource] /
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:
339385
Clinical trials.
Index Terms--Genre/Form:
336502
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[electronic resource] /
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http://www.karger.com/Book/Home/254780
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