Bilingual Reading

ID

English (US)

Chinese Simplified (简体中文)

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BACKGROUND 背景

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XX is a clinical research organization principally engaged in the design, set-up and management of research studies, and other related services, on behalf of the producers of pharmaceutical products. XX 是一家临床研究机构,该机构主要业务是代表医药产品生产商对研究项目进行设计、组织、管理并提供其他相关服务。

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XX’S client, (hereinafter known as the “Sponsor”) is sponsoring a non-interventional study involving patients with \[Specify Indication] (hereinafter called the “Study Indication”). XX 的客户<输入出资人名称>(以下简称“出资人”)为与出现\[列出指征](以下简称“研究指征”)的患者相关的非干预性研究项目提供资助。

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The Institution and its staff, including without limitation the principal investigator, are experienced in the evaluation and treatment of patients with Study Indication. 机构及其员工(包括但不限于项目负责人)在对出现研究指征的患者进行评估与治疗方面经验丰富。

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XX wishes to engage the Institution to conduct a Study (defined below) and the Institution wishes to conduct such a study. XX 希望聘用机构开展一个项目(定义见下文),机构希望开展该项目。

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IT IS HEREBY AGREED AS FOLLOWS: 各方在此就以下条款达成一致:

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As used in this Agreement, the following terms shall have the meanings set out below: 在本协议中,以下术语具有下文规定的含义:

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Case Report Form (CRF) 《病例报告表》

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Report in a format prepared by the Sponsor and/or XX and completed by the principal investigator documenting all tests and observations related to the Study (as hereinafter defined). 格式由出资人及/或 XX 编制,由项目负责人填写的报告,记录与项目(定义见下文)相关的所有测试与观察。

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Consent Form 《同意表》

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The form prepared by XX/the Sponsor in conformance with the Regulations (as hereinafter defined), in consultation with the Sponsor, XX, and the IRB/IEC (as hereinafter defined), approved by the IRB/IEC (if applicable) and signed by all participants before they begin to participate in the Study. XX /出资人依据法规(定义见下文),在与出资人、XX、IRB/IEC(定义见下文)协商后编制,由 IRB/IEC 批准(如果适用),并由所有参与者在开始参与项目之前签字的表格。

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The board, committee or other group formally instituted to review and approve the initiation of, and conduct reviews of, biomedical research involving human subjects. 正式设立,对涉及人类受试者的生物医学研究的启动进行审查与批准,并对其过程进行审查的理事会、委员会或其他团体。

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Protocol 协定

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The details of the Study contained in PROTOCOL NUMBER , \[and which is attached as Appendix 1 to this Agreement] NOTE: if it is not attached you must reference the date of the final version and together with any amendments (as agreed by the parties) made thereto is incorporated herein by reference as part of this Agreement. 协定编号<输入协定编号> \[作为本协议附件 1 随附。注意:如果没有随附,则贵方必须列出最终版本以及对其进行的任一修正(各方达成一致)的日期]包含的项目详情通过引用作为本协议一部分而纳入本协议。

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Qualified Participant 合格参与者

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Any potential participant who upon entrance into the Study, meets all of the inclusion criteria and none of the exclusion criteria set forth in the Protocol and has signed a valid IRB/IEC approved Consent Form. 进入项目时满足协定规定的所有入选标准,不满足协定规定的所有排除标准,并已在经 IRB/IEC 批准的有效《同意表》上签字的潜在参与者。

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Regulations 法规

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Any relevant legislation, codes or guidelines directly or indirectly related to the conduct of the Study. 与项目开展直接或间接相关的法律、准则或指引。

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For the avoidance of doubt such legislation, codes or guidance shall include those related to the protection and privacy of the personal data of individuals. 为予以澄清,该等法律、准则或指引应包括与个人数据保护与隐私相关的法律、准则或指引。

Industry

Technology

Subject

Computers (general)

Product

General

Our Task

TEP (translation, edition, proofreading)

Source File Format

sdlxliff

Skills Involved or Tools Used

Transee, DTP