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2017-8-10 品格翻譯繼續(xù)為某光學產(chǎn)品公司提供法律翻譯(Legal Translation),翻譯內(nèi)容:《臨床研究協(xié)議》。
譯文摘錄(保密內(nèi)容以XXX代替):

       
Clinical Study

臨床研究

The details of the clinical protocol will be summarized in a mutually agreeable Statement of Work and will be detailed in a mutually agreeable clinical protocol (“Protocol”).  To the extent any terms or provisions of the Statement of Work or Protocol conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the Statement of Work expressly and specifically states an intent to supersede this Agreement on a specific matter. The Statement of Work will be attached hereto as an Exhibit and incorporated herein by reference.

臨床試驗方案的細節(jié)將在雙方約定的《工作說明》中予以總結(jié),并將在相互同意的臨床試驗方案(“試驗方案”)中予以詳細說明。若《工作說明》或試驗方案所載的任何條款或規(guī)定與本協(xié)議的條款與規(guī)定相沖突的,應以本協(xié)議的條款與規(guī)定為主,《工作說明》明確且特別聲明其在具體事宜上取代本協(xié)議的除外?!豆ぷ髡f明》將通過引用并入本協(xié)議,并作為其附件。

Conduct of CLINICAL STUDY

臨床研究的開展

XXX shall propose to Sponsor (a) one or more site(s) at which to conduct the Clinical Study (“Study Site(s)”), and (b) for each Study Site, the principal investigator who will conduct the Clinical Study at that Study Site (“Site Principal Investigator”).  Sponsor shall make the final selection and approve each individual Study Site and Site Principal Investigator. Sponsor shall make such selection and give such approval at its sole discretion, and may reject any Study Site and/or Site Principal Investigator for any reason.  Upon Sponsor’s rejection of any Study Site and/or Site Principal Investigator, XXX shall promptly propose a new Study Site and/or new Site Principal Investigator.

XXX應向申辦者提議(a)開展臨床研究的一個或多個臨床試驗機構(gòu)(“研究機構(gòu)”),及(b)對于每個臨床試驗機構(gòu),將在該研究機構(gòu)開展臨床研究的首席研究員(“機構(gòu)首席研究員”)。申辦者應最終選擇并批準各研究機構(gòu)及機構(gòu)首席研究員。申辦者應酌情做出該等選擇并批準,并可以任何理由拒絕任何研究機構(gòu)和/或機構(gòu)首席研究員。申辦者拒絕任何研究機構(gòu)和/或機構(gòu)首席研究員之后,XXX應及時提議新的研究機構(gòu)和/或新的機構(gòu)首席研究員。

XXX will assure conduct of the Protocol and Statement of Work in accordance with the terms and conditions of this Agreement.

XXX將確保根據(jù)本協(xié)議的條款與條件執(zhí)行試驗方案與《工作說明》。

XXX shall be responsible for ensuring that the Site Principal Investigators and all other individuals assisting with the study (collectively, “Study Personnel”) use the highest standards of care, skill, and diligence used by persons who are skilled, trained and experienced with respect to the type of services required by the Protocol to conduct the Protocol in accordance with (a) the applicable Statement of Work; and (b) all recognized medical and ethical standards for the conduct of research or clinical investigations.

XXX應負責確保,機構(gòu)首席研究員和協(xié)助研究的所有其他人員(合稱“研究人員”)根據(jù)(a)相關《工作說明》及(b)所有被認可的開展研究或臨床研究的醫(yī)學及道德標準使用熟練、受訓且經(jīng)驗豐富的人員所使用的與試驗方案所規(guī)定的服務類型相關的最高標準的審慎、技能和勤勉程度執(zhí)行試驗方案。

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