Guide for investigator initiated tri...
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
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