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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(yàn)方案的細(xì)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(yàn)方案（“試驗(yàn)方案”）中予以詳細(xì)說明。若《工作說明》或試驗(yàn)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(yīng)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(yīng)向申辦者提議（a）開展臨床研究的一個(gè)或多個(gè)臨床試驗(yàn)機(jī)構(gòu)（“研究機(jī)構(gòu)”），及（b）對(duì)于每個(gè)臨床試驗(yàn)機(jī)構(gòu)，將在該研究機(jī)構(gòu)開展臨床研究的首席研究員（“機(jī)構(gòu)首席研究員”）。申辦者應(yīng)最終選擇并批準(zhǔn)各研究機(jī)構(gòu)及機(jī)構(gòu)首席研究員。申辦者應(yīng)酌情做出該等選擇并批準(zhǔn)，并可以任何理由拒絕任何研究機(jī)構(gòu)和/或機(jī)構(gòu)首席研究員。申辦者拒絕任何研究機(jī)構(gòu)和/或機(jī)構(gòu)首席研究員之后，XXX應(yīng)及時(shí)提議新的研究機(jī)構(gòu)和/或新的機(jī)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(yàn)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(yīng)負(fù)責(zé)確保，機(jī)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(guān)《工作說明》及（b）所有被認(rèn)可的開展研究或臨床研究的醫(yī)學(xué)及道德標(biāo)準(zhǔn)使用熟練、受訓(xùn)且經(jīng)驗(yàn)豐富的人員所使用的與試驗(yàn)方案所規(guī)定的服務(wù)類型相關(guān)的最高標(biāo)準(zhǔn)的審慎、技能和勤勉程度執(zhí)行試驗(yàn)方案。