{"title":"Report of the 3rd Annual Meeting of the Hokkaido & Tohoku Regions of the JSCPT","authors":"A. Inano","doi":"10.3999/jscpt.50.239","DOIUrl":"https://doi.org/10.3999/jscpt.50.239","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83142489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Terada, M. Kobayakawa, H. Ohtsu, S. Saito, Akira Kitagawa, K. Izumi, Hiroshi Watanabe
{"title":"Efforts to Promote and Facilitate Clinical Research Through Template Document Creation ―NIH-FDA Clinical Trial Protocol Template and the Application under Japanese Regulation―","authors":"M. Terada, M. Kobayakawa, H. Ohtsu, S. Saito, Akira Kitagawa, K. Izumi, Hiroshi Watanabe","doi":"10.3999/jscpt.50.183","DOIUrl":"https://doi.org/10.3999/jscpt.50.183","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77211765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reconsideration of Assent for Pediatric Clinical Research: A Tentative Disquisition and Proposals on an “Assent Form”","authors":"K. Matsui, Kaori Doi","doi":"10.3999/jscpt.49.219","DOIUrl":"https://doi.org/10.3999/jscpt.49.219","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78402489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Japanese Society of Clinical Pharmacology and Therapeutics
{"title":"Checklist in Reviewing Early-Stage Clinical Studies","authors":"The Japanese Society of Clinical Pharmacology and Therapeutics","doi":"10.3999/jscpt.49.183","DOIUrl":"https://doi.org/10.3999/jscpt.49.183","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85397246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sawako Hattori, K. Aizawa, Haruko Yamamoto, Shimon Tashiro, K. Matsui
{"title":"The Role of Consultation Services for Clinical Study Participants: a Survey of Progress on the Five Year Activation Plan for Clinical Study/Trial 2012","authors":"Sawako Hattori, K. Aizawa, Haruko Yamamoto, Shimon Tashiro, K. Matsui","doi":"10.3999/jscpt.49.127","DOIUrl":"https://doi.org/10.3999/jscpt.49.127","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79090360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Report of the 2nd Annual Meeting of the Kanto & Koushinetsu Regions of the JSCPT","authors":"T. Shiga","doi":"10.3999/JSCPT.49.105","DOIUrl":"https://doi.org/10.3999/JSCPT.49.105","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"37 1","pages":"105-108"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79899985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Maeda, T. Fujita, H. Amano, H. Kohara, A. Yamazaki, T. Hirayama, M. Kuroyama, M. Ogino, K. Nagashima, T. Akutsu, K. Nishiyama, Y. Kumagai
{"title":"Pharmacokinetics and Pharmacodynamics of a Single Dose of Scopolamine Ointment Applied to the Postauricular Area in Healthy Subjects","authors":"M. Maeda, T. Fujita, H. Amano, H. Kohara, A. Yamazaki, T. Hirayama, M. Kuroyama, M. Ogino, K. Nagashima, T. Akutsu, K. Nishiyama, Y. Kumagai","doi":"10.3999/JSCPT.49.53","DOIUrl":"https://doi.org/10.3999/JSCPT.49.53","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"34 1","pages":"53-58"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81154428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Toshiko Miyamoto, Akiyo Akaishi, Tomoko Takagai, K. Kida, M. Akaike, H. Yanagawa
Background and objectives: In Japan, the contribution of clinical research coordinators to trials for drug approval is now well recognized in investigators. In 2013, we initiated a clinical research coordinator hospital certification course at our facility. The purpose of the course is to pre-educate medical staff who are candidates for future roles of clinical research coordinator, and to spread recognition of clinical research. Methods: To obtain information from course participants, we conducted a qualitative study in 2014, using a focus group interview in six participants who had completed the course in 2013. The initial topic was perceptions of the course before and after participation. Other topics were the present status and issues in clinical research coordinators. Results: All participants agreed that the course was acceptable and effective in reexamining their own work and roles from the aspects of clinical research, and that the role of clinical research coordinator itself is not very familiar among staff in the facility. Some participants indicated that even their more senior coworkers have limited recognition about clinical research coordinators. Conclusion: There are few reports that deal with awareness-spreading activities that targeted facility staff in positions other than those related to clinical research. This type of education could be considered to more quickly build support of clinical research
{"title":"Implementation of Clinical Research Coordinator Hospital Certification Course to Spread Understanding of Clinical Trials","authors":"Toshiko Miyamoto, Akiyo Akaishi, Tomoko Takagai, K. Kida, M. Akaike, H. Yanagawa","doi":"10.3999/JSCPT.49.7","DOIUrl":"https://doi.org/10.3999/JSCPT.49.7","url":null,"abstract":"Background and objectives: In Japan, the contribution of clinical research coordinators to trials for drug approval is now well recognized in investigators. In 2013, we initiated a clinical research coordinator hospital certification course at our facility. The purpose of the course is to pre-educate medical staff who are candidates for future roles of clinical research coordinator, and to spread recognition of clinical research. \u0000Methods: To obtain information from course participants, we conducted a qualitative study in 2014, using a focus group interview in six participants who had completed the course in 2013. The initial topic was perceptions of the course before and after participation. Other topics were the present status and issues in clinical research coordinators. \u0000Results: All participants agreed that the course was acceptable and effective in reexamining their own work and roles from the aspects of clinical research, and that the role of clinical research coordinator itself is not very familiar among staff in the facility. Some participants indicated that even their more senior coworkers have limited recognition about clinical research coordinators. \u0000Conclusion: There are few reports that deal with awareness-spreading activities that targeted facility staff in positions other than those related to clinical research. This type of education could be considered to more quickly build support of clinical research","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"34 1","pages":"7-11"},"PeriodicalIF":0.0,"publicationDate":"2018-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73109736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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