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A Guide to an Effective Clinical Trial Protocol in CGMP CGCP as a Tool for Sustenance of Ethical Principles and Regulatory Requirements in the Pharmaceutical and Research Industry

机译：CGMP＆CGCP中有效临床试验协议的指南，作为制药和研究行业的伦理原则和监管要求的工具

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Peter Odeh;
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1. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees [J] . Li Rebecca H., Wacholtz Mary C., Barnes Mark, Journal of medical ethics . 2016,第4期

机译：将伦理原则纳入临床研究方案：方案作者和伦理委员会的工具
2. Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials [J] . W. Pinxten (El) K. Dierickx H. Nys European journal of pediatrics . 2009,第10期

机译：欧盟儿科研究的伦理原则和法律要求：围绕儿科临床试验的欧洲规范和法律框架的分析
3. Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials [J] . Wim Pinxten, Kris Dierickx, Herman Nys European Journal of Pediatrics . 2009,第10期

机译：欧盟儿科研究的伦理原则和法律要求：围绕儿科临床试验的欧洲规范和法律框架的分析
4. Adequate preliminary animal research and reported data in pre-clinical trials for acute renal insufficiency: a historic example of scientific-ethical protocol from the 1940s [C] . Fagette P. Engineering in Medicine and Biology, 2002. 24th Annual Conference and the Annual Fall Meeting of the Biomedical Engineering Society EMBS/BMES Conference, 2002. Proceedings of the Second Joint . 2002

机译：足够的初步动物研究和临床前试验中报道的急性肾功能不全的数据：1940年代科学伦理协议的历史性例子
5. Offshoring and outsourcing of core corporate activities: The global relocation of pharmaceutical industry clinical trials. [D] . Thakur, Pooja. 2010

机译：公司核心业务的离岸外包和外包：制药行业临床试验的全球迁移。
6. Paper: Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees [O] . Rebecca H Li, Mary C Wacholtz, Mark Barnes, -1

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7. Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey [O] . Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, 2019

机译：参与者参与制药行业临床试验期间道德合规性，安全和保护的认识：受控调查
8. Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Questions and Answers(R2), Revision 1. [R] . 2013

机译：行业指南：m3（R2）人体临床试验行为和药品营销许可的非临床安全性研究。问题与解答（R2），修订版1。

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A Guide to an Effective Clinical Trial Protocol in CGMP CGCP as a Tool for Sustenance of Ethical Principles and Regulatory Requirements in the Pharmaceutical and Research Industry

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