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Legal Regulatory and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

机译：采用分散临床试验时要考虑的法律法规和实践问题：临床试验转化计划的建议

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摘要

Challenges and Suggested Solutions from the Interviews and Considerations from the Expert Meeting.

机译：专家会议的访谈和考虑中的挑战和建议的解决方案。

著录项

期刊名称 Springer Open Choice
作者
Maria Apostolaros; David Babaian; Amy Corneli; Annemarie Forrest; Gerrit Hamre; Jan Hewett; Laura Podolsky; Vaishali Popat; Penny Randall;
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作者单位

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年(卷),期 -1(54),4
年度 -1
页码 -1
总页数 9
原文格式 PDF
正文语种
中图分类外科学;
关键词
Mobile clinical trials; Mobile technology; Mobile medical applications; Mobile nursing; Participant-centric trials; Telehealth;

机译：移动临床试验;移动技术;移动医疗应用;移动护理;以参与者为中心的试验;远程医疗;

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专利

1. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative [J] . Apostolaros Maria, Babaian David, Corneli Amy, Therapeutic innovation & regulatory science. . 2020,第4期

机译：采用分散式临床试验时的法律，监管和实际问题：临床试验转型倡议的建议
2. Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative [J] . Coran P., Goldsack J.C., Grandinetti C.A., Digital biomarkers. . 2019,第3期

机译：在临床试验中推进移动技术的使用：临床试验转型倡议的建议
3. Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team [J] . Knirsch Charles, Alemayehu Demissie, Botgros Radu, Clinical infectious diseases . 2016,第Suppla2期

机译：改善临床试验的行为和可行性，以评估用于治疗医院获得性细菌性肺炎和呼吸机相关细菌性肺炎的抗菌药物：临床试验转化计划抗菌药物开发项目小组的建议
4. Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms [C] . Forgo Nikolaus, Goralczyk Magdalena, Hanold Stefanie Annual Conference of Japanese Society for Medical and Biological Engineering;Annual International Conference of the IEEE Engineering in Medicine and Biology Society . 2013

机译：在临床试验中控制患者-通过法律规范的技术实施来提高临床试验中患者的能力的欧洲倡议
5. Globalization of clinical research trials in India: Determining the quality of Indian clinical trials through the use of the Jadad scale [D] . Groesser, Kirsten J. 2010

机译：印度临床研究试验的全球化：通过使用Jadad量表确定印度临床试验的质量
6. Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative [O] . Philip Coran, Jennifer C. Goldsack, Cheryl A. Grandinetti, 2019

机译：在临床试验中促进移动技术的使用：临床试验转型计划的建议
7. Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team [O] . Charles Knirsch, Demissie Alemayehu, Radu Botgros, 2016

机译：提高临床试验的行为和可行性，以评估抗菌药物治疗医院收养的细菌肺炎和呼吸机相关的细菌肺炎：临床试验的建议转型促进抗菌药物开发项目团队
8. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Executive Summary; Volume 1. Report and Recommendations of the National Bioethics Advisory Commission; and Volume 2. Commissioned Papers and Staff Analysis. [R] . 2001

机译：国际研究中的伦理与政策问题：发展中国家的临床试验。执行摘要;第1卷。国家生物伦理咨询委员会的报告和建议;和第2卷。委托论文和工作人员分析。

Legal Regulatory and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

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