• Guide for investigator initiated trials
  • [NT 42944] Record Type: [NT 8598] Electronic resources : [NT 40817] monographic
    [NT 47261] Author: FortwengelGerhard,
    [NT 47351] Place of Publication: Basel
    [NT 47263] Published: Karger;
    [NT 47352] Year of Publication: c2011
    [NT 47264] Description: 1 online resource
    [NT 47266] Subject: Clinical trials -
    [NT 47266] Subject: Clinical Trials as Topic -
    [NT 47266] Subject: Research Design -
    [NT 47266] Subject: Electronic books -
    [NT 51458] Online resource: http://www.karger.com/Book/Home/254780
    [NT 47265] Notes: Description based on print version record
    [NT 50961] ISBN: 9783805596855electronic bk.
    [NT 50961] ISBN: 3805596855electronic bk.
    [NT 60779] Content Note: 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
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