@misc{oai:repo.qst.go.jp:00063726,
 author = {Kurihara, Chieko and Fukushima, Yoshiko and Itoh, Hisahiro and Hirata, Tomoko and Inano, Akihiro and Sugiyama, Yuichi and 栗原 千絵子 and 福島 芳子},
 month = {Nov},
 note = {[Purpose] To develop the system of managing multiplex clinical studies in the Research Project for Establishment of Evolutional Drug Development with the Use of Microdose Clinical Trial, to assure quality of the studies and human subjects protection. [Methods] A Clinical Research Management Team has been established and practical management, discussion meetings, and document development work have been conducted as part of the research project.
[Results and Discussion] The following items were identified as the essential elements in the management system of multiplex studies: (1) visiting and quality check of the clinical sites and of the product manufacturing sites; (2) organizing several bodies for radiological protection of human subjects; (3) systematic literature search and inquiry for safety issues and error recovery procedures; (4) systematic documentation and SOP (standard operating procedure)/guidance development; and (5) Ethics Committees submission support. Some of these procedures seem to provide some hints to redesign clinical drug development in Japan. [Conclusions] The clinical research management system we have developed would be useful especially for conducting new types of studies such as microdosing clinical studies and molecular imaging PET studies.
[Acknowledgement] This and the following 5 studies are sponsored by the New Energy and Industrial Technology Development Organization (NEDO)., 第24回日本薬物動態学会年会},
 title = {INNOVATIVE STRATEGIES FOR DRUG DEVELOPMENT USING MICRODOSING CLINICAL STUDIES  (1)Ethics and Human Subjects Protection In The Project of Multiplex Studies},
 year = {2009}
}