英文翻译_首发：2020中国GCP英文翻译版

图片来自网络

免费获取《药物临床试验质量管理规范_2020_中英文对照版》及《Good Clinical Practice (GCP)_2020_English Version》的步骤如下(自愿原则)：

1，敬请将本文转发至您的微信朋友圈 (万分感谢！)

2，点击本文标题下方“MedTalk Studio”字样，并关注公众号

3，进入公众号，在信息对话框中输入“已转”并发送

4，您将收到一条自动回复的信息，包含存储以上两个文件的百度网盘链接及提取码，下载获取完整文件

友情提示：您需要有百度网盘的账号才能下载完整版文件(中英文对照版有67页，纯英文翻译版有40页)

郑重声明：本文涉及和提供的2020中国GCP英文翻译版本仅供对此有兴趣的人员参考交流之用，不做为任何商业用途。

中英文对照版示例：

第一章 总 则

Chapter I General Provisions

第一条 为保证药物临床试验过程规范，数据和结果的科学、真实、可靠，保护受试者的权益和安全，根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《中华人民共和国药品管理法实施条例》，制定本规范。本规范适用于为申请药品注册而进行的药物临床试验。药物临床试验的相关活动应当遵守本规范。

1. This Good Clinical Practice (GCP) Guideline is developed in accordance with the Pharmaceutical Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, and the Regulations on the implementation of the Pharmaceutical Administration Law of the People's Republic of China. The objective of this GCP guideline is to ensure the compliance of the overall conduct of clinical trials, ensure that the data and results are scientific, reliable and credible, and protect the rights and safety of the trial subjects. This guideline is applicable to the clinical trials for the application of drug registrations. The relevant activities of clinical trials should comply with this guideline.

第二条 药物临床试验质量管理规范是药物临床试验全过程的质量标准，包括方案设计、组织实施、监查、稽查、记录、分析、总结和报告。

2. Good Clinical Practice (GCP) is a quality standard for the overall conduct of the clinical trial, including the protocol design, conduct, monitoring, auditing, recording, analyses, summarizing and reporting of the clinical trial.

第三条 药物临床试验应当符合《世界医学大会赫尔辛基宣言》原则及相关伦理要求，受试者的权益和安全是考虑的首要因素，优先于对科学和社会的获益。伦理审查与知情同意是保障受试者权益的重要措施。

3. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, the rights and safety of the trial subjects are the most important considerations and should prevail over interests of science and society. Both EC review and informed consent are important measures to protect the rights of the subjects.

第四条 药物临床试验应当有充分的科学依据。临床试验应当权衡受试者和社会的预期风险和获益，只有当预期的获益大于风险时，方可实施或者继续临床试验。

4. Clinical trials should be scientifically sound. Before a trial is initiated, foreseeable risks should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

第五条 试验方案应当清晰、详细、可操作。试验方案在获得伦理委员会同意后方可执行。

5. The trial protocol should be clear, detailed and performable. The protocol can be implemented only when it is approved by the Ethics Committee (EC).

第六条 研究者在临床试验过程中应当遵守试验方案，凡涉及医学判断或临床决策应当由临床医生做出。参加临床试验实施的研究人员，应当具有能够承担临床试验工作相应的教育、培训和经验。

6. The investigator should conduct the clinical trial in accordance with the protocol, any medical judgment or medical decision should be made by qualified physician. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

第七条 所有临床试验的纸质或电子资料应当被妥善地记录、处理和保存，能够准确地报告、解释和确认。应当保护受试者的隐私和其相关信息的保密性。

7. All the clinical trial information (paper or electronic) should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. Subject’s privacy and confidentiality related information should be protected.

第八条 试验药物的制备应当符合临床试验用药品生产质量管理相关要求。试验药物的使用应当符合试验方案。

8. The study drug should be manufactured and handled in accordance with applicable good manufacturing practice and related quality requirements for the investigational product(s). The study drug should be used in accordance with the protocol.

第九条 临床试验的质量管理体系应当覆盖临床试验的全过程，重点是受试者保护、试验结果可靠，以及遵守相关法律法规。

9. The quality management system of the clinical trial should cover the whole process of the clinical trial, focusing on the protection of subjects, reliability of trial results and compliance to applicable regulatory requirements.

第十条 临床试验的实施应当遵守利益冲突回避原则。

10. The conduct of clinical trials should follow the principle of conflict of interest avoidance.