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JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS最新文献

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2020年度日本臨床薬理学会海外研修員報告： 研修完了報告書 2020年度日本临床薬理学会海外研修员报告： 研修完了报告书
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_89
Ryuji Uozumi
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引用次数: 0
Proactive Learning Program on Research Integrity in Clinical Research Training 临床研究训练中研究诚信的主动学习计划
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_55
Rie Nishimura, Jiro Takeuchi, M. Sakuma, Mari Nezu, K. Uchida, Miki Higaonna, Norito Kinjo, Fumihiro Sakakibara, Tsukasa Nakamura, Shinji Kosaka, Shinichi Yoshimura, S. Ueda, T. Morimoto
{"title":"Proactive Learning Program on Research Integrity in Clinical Research Training","authors":"Rie Nishimura, Jiro Takeuchi, M. Sakuma, Mari Nezu, K. Uchida, Miki Higaonna, Norito Kinjo, Fumihiro Sakakibara, Tsukasa Nakamura, Shinji Kosaka, Shinichi Yoshimura, S. Ueda, T. Morimoto","doi":"10.3999/jscpt.54.2_55","DOIUrl":"https://doi.org/10.3999/jscpt.54.2_55","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42762894","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}
引用次数: 0
How Do Academic Society Editorial Boards Handle Nonregulated Research? 学会编辑委员会如何处理不受管制的研究?
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_77
T. Dohzono, Tatsuya Watanabe, Akiko Nakada, A. Ujihara, E. Arita
{"title":"How Do Academic Society Editorial Boards Handle Nonregulated Research?","authors":"T. Dohzono, Tatsuya Watanabe, Akiko Nakada, A. Ujihara, E. Arita","doi":"10.3999/jscpt.54.2_77","DOIUrl":"https://doi.org/10.3999/jscpt.54.2_77","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47227421","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}
引用次数: 0
Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital 通过修订偏差报告和分类偏差病例优化临床试验管理，有效提高旭川医科大学附属医院临床试验质量
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_71
Masumi Ogawa, Takayuki Manabe, Yuko Kondo, Sachie Hatayama, Kanae Tani, Miyuki Sato, Mariko Yokoyama, Kazumi Yuki, Naoya Kamiyama, M. Honma, Yoshikazu Tasaki, S. Matsumoto
Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
现场监测期间的面对面沟通对临床试验质量保证至关重要。然而，随着2020年初冠状病毒大流行，医疗机构对医院就诊进行了限制，以确保其医疗系统的安全。旭川医科大学医院同样对门诊和住院病人进行限制，并对外部供应商进行法律限制。因此，减少了在我院进行临床试验的现场监测频率。由于即使在2年后感染单位也没有趋同的迹象，我们在系统审查中调查了现场监测的频率和临床试验偏差的频率。此外，虽然在2019财年编制了临床试验偏差报告表格(以前的表格)，但其中有许多自由描述，并且许多偏差报告难以理解。同样，有些情况下，偏差没有记录在偏差报告表上，而只记录在物品记录(源文件)上，例如与申办方协商后的电子病历，并且偏差没有以统一的格式记录。因此，医院很难将偏离事件的数量制成表格并进行分类。根据这一经验，本报告描述了修订临床试验偏差报告、明确报告内容、建立制度明确临床试验偏差发生相关流程的进展情况。版权所有:©2023日本临床药理学和治疗学学会(JSCPT)。
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引用次数: 0
現地開催！スタディマネジャー/プロジェクトマネジャーつながり対話会 现场举办!研究经理/项目经理对话
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_85
R. Asada, M. Ichimura, Akiko Imai, Kanae Iwata, Yukitoshi Ohta, Kayoko Kikuchi, Koichi Konno, Yoshiko Takagi, T. Terada, Naoko Hagimori, Erika Horibe, Yoshio Marumoto
{"title":"現地開催！スタディマネジャー/プロジェクトマネジャーつながり対話会","authors":"R. Asada, M. Ichimura, Akiko Imai, Kanae Iwata, Yukitoshi Ohta, Kayoko Kikuchi, Koichi Konno, Yoshiko Takagi, T. Terada, Naoko Hagimori, Erika Horibe, Yoshio Marumoto","doi":"10.3999/jscpt.54.2_85","DOIUrl":"https://doi.org/10.3999/jscpt.54.2_85","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48400751","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}
引用次数: 0
Pitfalls of Healthcare Economics as Considered by Healthcare Professionals―Things They Should Know Before Discussing Healthcare Rationing in a Medical Setting 医疗保健专业人员认为的医疗保健经济学陷阱——在医疗机构讨论医疗配给之前他们应该知道的事情
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-03-31 DOI: 10.3999/jscpt.54.2_63
Keiichiro Yamamoto, T. Mizutani, T. Iwatani
{"title":"Pitfalls of Healthcare Economics as Considered by Healthcare Professionals―Things They Should Know Before Discussing Healthcare Rationing in a Medical Setting","authors":"Keiichiro Yamamoto, T. Mizutani, T. Iwatani","doi":"10.3999/jscpt.54.2_63","DOIUrl":"https://doi.org/10.3999/jscpt.54.2_63","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47145821","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}
引用次数: 0
Current Status of Electronic Informed Consent: Results of Web-based Survey Targeting Clinical Research Coordinators 电子知情同意的现状:针对临床研究协调员的网络调查结果
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-01-31 DOI: 10.3999/jscpt.54.1_19
M. Terada, Yayoi Sato, T. Osawa, Yoshihiko Iijima, Miho Goto, A. Tamaura
{"title":"Current Status of Electronic Informed Consent: Results of Web-based Survey Targeting Clinical Research Coordinators","authors":"M. Terada, Yayoi Sato, T. Osawa, Yoshihiko Iijima, Miho Goto, A. Tamaura","doi":"10.3999/jscpt.54.1_19","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_19","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48834943","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}
引用次数: 0
Differing Patterns of Diurnal Variation and Impact of Antacids on Levodopa Pharmacokinetics in Patients with Parkinson's Disease 帕金森病患者昼夜变化的不同模式及抗酸剂对左旋多巴药代动力学的影响
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-01-31 DOI: 10.3999/jscpt.54.1_3
M. Nagai, S. Tada, Y. Yamanishi, N. Miyaue, R. Ando
{"title":"Differing Patterns of Diurnal Variation and Impact of Antacids on Levodopa Pharmacokinetics in Patients with Parkinson's Disease","authors":"M. Nagai, S. Tada, Y. Yamanishi, N. Miyaue, R. Ando","doi":"10.3999/jscpt.54.1_3","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_3","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46067607","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}
引用次数: 1
Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physician-initiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases 在未获得监管机构批准的由医生发起的心血管疾病临床试验中，由早期、风险适应、触发的现场监测发现的错误
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-01-31 DOI: 10.3999/jscpt.54.1_9
Yumi Ikehara, T. Morimoto, M. Ikeda, K. Node, S. Ueda
{"title":"Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physician-initiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases","authors":"Yumi Ikehara, T. Morimoto, M. Ikeda, K. Node, S. Ueda","doi":"10.3999/jscpt.54.1_9","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_9","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46993667","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}
引用次数: 0
Analysis of Pathogenesis of Drug-associated Neurotoxicity by Proteomics and Pharmacogenetics 药物相关神经毒性发病机制的蛋白质组学和药物遗传学分析
Q4 Medicine
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Pub Date : 2023-01-31 DOI: 10.3999/jscpt.54.1_49
M. Yanagimachi
{"title":"Analysis of Pathogenesis of Drug-associated Neurotoxicity by Proteomics and Pharmacogenetics","authors":"M. Yanagimachi","doi":"10.3999/jscpt.54.1_49","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_49","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43379672","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}
引用次数: 0
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