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Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies

机译：全国关于医院的知情同意和道德审查调查，进行制药公司赞助的营销后的营销研究

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Hisashi Urushihara; Yuka Murakami; Kenji Matsui; Shimon Tashiro;
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年度 2018
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1. Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies [J] . Urushihara Hisashi, Murakami Yuka, Matsui Kenji, 藥學雜誌 . 2018,第1期

机译：全国关于医院开展医药售后研究的知情同意和道德审查调查
2. Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company. [J] . Beran RG Medicine and law . 2004,第4期

机译：作为调查人员在澳大利亚为一家海外制药公司发起和赞助研究，因此在澳大利亚进行临床药物试验的法律和道德义务。
3. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension. [J] . Virginia Sanchini, Michele Reni, Giliola Calori, Journal of medical ethics . 2014,第4期

机译：知情同意是临床试验中的一项道德要求：一个古老但尚未解决的问题。一项观察性研究，以评估患者的知情同意理解。
4. Electronic Processing of Informed Consents in a Global Pharmaceutical Company Environment [C] . Dina VISHNYAKOVA, Julien GOBEILL, Fatma OEZDEMIR-ZAECH, European Federation for Medical Informatics., Conference . 2014

机译：在全球制药公司环境中的知情同意电子处理
5. Informed Consent in the Context of Left Ventricular Assist Device Use as Destination Therapy (LVAD-DT): A Systematic Review and Ethical Analysis [D] . Friedman, James. 2020

机译：在左心室辅助装置的背景下的知情同意用作目的地治疗（LVAD-DT）：系统审查和道德分析
6. Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study [O] . Kirsten Kortram, Emerentia Q W Spoon, Sohal Y Ismail, 2016

机译：朝着活体供体肾切除术的标准化知情同意程序迈进：PRINCE（知情同意评估过程）项目—一项针对全国性前瞻性队列研究的研究方案
7. Studies on the merits and demerits of subjects in the company and informed consent in phase I clinical study. Based upon the collected results of a questionnaire survey of subjects of a study conducted by the Hamamatsu University, School of Medicine. [O] . MITSUTAKA KANAMARU 1988

机译：我临床研究中公司科目和知情同意的研究。基于由滨松大学，医学院开展的研究问卷调查结果。
8. Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements, 21 CFR Section 50.25(c) (Small Entity Compliance Guide) [R] . 2012

机译：赞助商，调查员和机构审查委员会的指南：关于知情同意要素的问题和解答，21 CFR第50.25（c）节（小实体合规指南）

Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies

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