<b>Survey </b><b>on Centralization of Research Ethics Review for Multicenter Clinical Trials in Japan </b>
Volume: 49, Issue: 4, Pages: 159 - 167
Published: Jul 31, 2018
Abstract
We conducted a survey on centralization of research ethics review for multicenter clinical trials under the Pharmaceuticals and Medical Devises Law and calculated the “deinstitutionalization (referred to review not conducted by local IRB)” rate for each type of clinical trial. We confirmed a trend of increase in overall deinstitutionalization rate from FY2008 to FY2013. The rate was 64.5% for phase III clinical trials in FY2013. However, the...
Paper Details
Title
<b>Survey </b><b>on Centralization of Research Ethics Review for Multicenter Clinical Trials in Japan </b>
Published Date
Jul 31, 2018
Volume
49
Issue
4
Pages
159 - 167
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