GCP考試試卷帶答案（能力提升）

GCP/r/n考/r/n試試/r/n卷/r/n一/r/n./r/n選擇題/r/n(/r/n共/r/n50/r/n題/r/n，共/r/n100/r/n分/r/n)/r/n1./r/n倫理委員會的工作記錄，下列哪一項是不對的？/r/nA.書面記錄所有會議的議事/r/nB/r/n./r/n只有作出決議的會議需要記錄/r/nC/r/n./r/n記錄保存至臨床試驗結(jié)束后五年/r/nD/r/n./r/n書面記錄所有會議及其決議/r/n2./r/n倫理委員會的意見不可以是：/r/nA./r/n同意/r/n

/r/nB/r/n./r/n不同意/r/nC/r/n./r/n作必要修正后同意/r/n

/r/nD/r/n./r/n作必要修正后重審/r/n3./r/n在臨床試驗方案中有關(guān)試驗藥品管理的規(guī)定不包括：/r/nA.藥品保存

/r/n

/r/nB.藥品分發(fā)/r/nC.藥品的登記與記錄/r/n

/r/nD.如何移交給非試驗人員/r/n4./r/n下列條件中，哪一項不是研究者應(yīng)具備的？/r/nA.在合法的醫(yī)療機構(gòu)中具有任職行醫(yī)的資格/r/nB具有試驗方案中所需要的專業(yè)知識和經(jīng)驗/r/nC具有行政職位或一定的技術(shù)職稱/r/nD熟悉申辦者所提供的臨床試驗資料和文獻(xiàn)/r/n5./r/n研究者對研究方案承擔(dān)的職責(zé)中不包括：/r/nA.詳細(xì)閱讀和了解方案內(nèi)容/r/nB試驗中根據(jù)受試者的要求調(diào)整方案/r/nC嚴(yán)格按照方案和本規(guī)范進(jìn)行試驗/r/nD與申辦者一起簽署試驗方案/r/n6./r/n倫理委員會審閱試驗方案中一般不考慮：/r/nA.受試者入選方法是否適當(dāng)/r/nB/r/n./r/n知情同意書內(nèi)容是否完整易懂/r/nC/r/n./r/n受試者是否有相應(yīng)的文化程度/r/nD/r/n./r/n受試者獲取知情同意書的方式是否適當(dāng)/r/n7./r/n《/r/n藥/r/n物/r/n臨/r/n床/r/n試驗質(zhì)/r/n量管理/r/n規(guī)/r/n范》何/r/n時頒/r/n布的？/r/nA.1998.3

/r/nB.2003.6/r/nC.1997.12

D.2003.8/r/n8./r/n下列哪項不在倫理委員會審閱方案的內(nèi)容之內(nèi)？/r/n

/r/nA.對受試者因參加臨床試驗受損時如何治療的規(guī)定/r/nB/r/n./r/n對受試者因參加臨床試驗死亡后如何補償?shù)囊?guī)定/r/nC/r/n./r/n對研究者因參加臨床試驗受損時如何補償?shù)囊?guī)定/r/nD/r/n./r/n對受試者因參加臨床試驗受損時如何補償?shù)囊?guī)定/r/n9./r/n病人或/r/n臨/r/n床/r/n試驗/r/n受/r/n試/r/n者接受一種/r/n藥/r/n品后出/r/n現(xiàn)/r/n的不良反/r/n應(yīng)/r/n事件，但不一定與治/r/n療/r/n有因果關(guān)系。/r/nA./r/n不良事件/r/n

/r/n

B./r/n嚴(yán)/r/n重不良事件/r/nC./r/n藥/r/n品不良反/r/n應(yīng)/r/n

D./r/n病例/r/n報/r/n告表/r/n10./r/n為/r/n有效地/r/n實/r/n施和完成某一/r/n臨/r/n床/r/n試驗/r/n中每/r/n項/r/n工作所/r/n擬/r/n定的/r/n標(biāo)/r/n準(zhǔn)而/r/n詳細(xì)/r/n的/r/n書/r/n面/r/n規(guī)/r/n程。/r/nA./r/n藥/r/n品/r/n

B./r/n標(biāo)/r/n準(zhǔn)操作/r/n規(guī)/r/n程/r/nC./r/n試驗/r/n用/r/n藥/r/n品/r/n

D./r/n藥/r/n品不良反/r/n應(yīng)/r/n11./r/n倫理委員會應(yīng)成立在：/r/nA.申辦者單位

/r/nB/r/n./r/n臨床試驗單位/r/nC/r/n./r/n藥政管理部門/r/n

/r/nD/r/n./r/n監(jiān)督檢查部門/r/n12./r/n一種學(xué)/r/n術(shù)/r/n性或商/r/n業(yè)/r/n性的科學(xué)機構(gòu)，申/r/n辦/r/n者可委托并/r/n書/r/n面/r/n規(guī)/r/n定其/r/n執(zhí)/r/n行/r/n臨/r/n床/r/n試驗/r/n中的某些工作和任/r/n務(wù)/r/n。/r/nA.CRO

/r/n

B.CRF/r/nC.SOP

D.SA.E/r/n13./r/n下列哪項不是受試者的應(yīng)有權(quán)利？/r/nA.愿意或不愿意參加試驗/r/nB/r/n./r/n參與試驗方法的討論/r/nC/r/n./r/n要求試驗中個人資料的保密/r/nD/r/n./r/n隨時退出試驗/r/n14./r/n下列哪些不是臨床試驗前的準(zhǔn)備和必要條件？/r/nA.必須有充分的理由/r/nB/r/n./r/n必須所有的病例報告表真實、準(zhǔn)確/r/nC/r/n./r/n申辦者準(zhǔn)備和提供臨床試驗用藥品/r/nD/r/n./r/n研究者充分了解中國有關(guān)藥品管理法/r/n15./r/n告知一/r/n項試驗/r/n的各個方面情況后，受/r/n試/r/n者自愿/r/n認(rèn)/r/n其同意參/r/n見該項臨/r/n床/r/n試驗/r/n的/r/n過/r/n程。/r/nA./r/n知情同意/r/n

B./r/n知情同意/r/n書/r/nC./r/n試驗/r/n方案/r/n

D./r/n研究者手冊/r/n16./r/n臨/r/n床/r/n試驗過/r/n程中/r/n發(fā)/r/n生需住院治/r/n療/r/n、延/r/n長/r/n住院/r/n時間/r/n、/r/n傷/r/n殘、影響工作能力、危及生命或死亡、/r/n導(dǎo)/r/n致先天畸形等事件。/r/nA./r/n嚴(yán)/r/n重不良事件/r/n

/r/n

B./r/n藥/r/n品不良反/r/n應(yīng)/r/nC./r/n不良事件/r/n

D./r/n知情同意/r/n17./r/n試驗/r/n完成后的一份/r/n詳/r/n盡/r/n總結(jié)/r/n，包括/r/n試驗/r/n方法和材料、/r/n結(jié)/r/n果描述與/r/n評/r/n估、/r/n統(tǒng)計/r/n分析以及最/r/n終/r/n所/r/n獲鑒/r/n定性的、合乎道德的/r/n統(tǒng)計/r/n學(xué)和/r/n臨/r/n床/r/n評/r/n價/r/n報/r/n告。/r/nA./r/n病例/r/n報/r/n告表/r/n

/r/nB./r/n總結(jié)報/r/n告/r/nC./r/n試驗/r/n方案/r/n

D./r/n研究者手冊/r/n18./r/n在多中心/r/n臨/r/n床/r/n試驗/r/n中/r/n負(fù)責(zé)協(xié)調(diào)/r/n各參加中心的研究者的工作的一名研究者。/r/nA./r/n協(xié)調(diào)/r/n研究者/r/n

B./r/n監(jiān)查員/r/nC./r/n研究者/r/n

D./r/n申/r/n辦/r/n者/r/n19./r/n發(fā)/r/n起一/r/n項臨/r/n床/r/n試驗/r/n，并/r/n對該試驗/r/n的啟/r/n動/r/n、管理、/r/n財務(wù)/r/n和/r/n監(jiān)查負(fù)責(zé)/r/n的公司、機構(gòu)和/r/n組織/r/n。/r/nA./r/n協(xié)調(diào)/r/n研究者/r/n

B./r/n監(jiān)查員/r/nC./r/n研究者/r/n

/r/nD./r/n申/r/n辦/r/n者/r/n20./r/n下列哪項不在藥品臨床試驗道德原則的規(guī)范之內(nèi)？/r/nA./r/n公正/r/n

/r/nB/r/n./r/n尊重人格/r/nC/r/n./r/n力求使受試者最大程度受益/r/nD/r/n./r/n不能使受試者受到傷害/r/n21./r/n由申/r/n辦/r/n者委任并/r/n對/r/n申/r/n辦/r/n者/r/n負(fù)責(zé)/r/n的人/r/n員/r/n，其任/r/n務(wù)/r/n是/r/n監(jiān)查/r/n和/r/n報/r/n告/r/n試驗/r/n的/r/n進(jìn)/r/n行情況和核/r/n實/r/n數(shù)據(jù)。/r/n

/r/nA./r/n協(xié)調(diào)/r/n研究者/r/n

/r/nB./r/n監(jiān)查員/r/nC./r/n研究者/r/n

D./r/n申/r/n辦/r/n者/r/n22./r/n關(guān)于知情同意書內(nèi)容的要求，下列哪項不正確？/r/nA.須寫明試驗?zāi)康?r/nB/r/n./r/n須使用受試者能理解的語言/r/nC/r/n./r/n不必告知受試者可能被分配到試驗的不同組別/r/nD/r/n./r/n須寫明可能的風(fēng)險和受益/r/n23./r/n下列條件中，哪一項不是研究者應(yīng)具備的？/r/nA.熟悉本規(guī)范并遵守國家有關(guān)法律、法規(guī)/r/nB具有試驗方案中所需要的專業(yè)知識和經(jīng)驗/r/nC熟悉申辦者所提供的臨床試驗資料和文獻(xiàn)/r/nD是倫理委員會委員/r/n24./r/n下列哪一項是臨床試驗前準(zhǔn)備的必要條件？/r/nA.必須有充分理由/r/nB/r/n./r/n研究單位和研究者需具備一定條件/r/nC/r/n./r/n所有受試者均已簽署知情同意書/r/nD/r/n./r/n以上三項必須同時具備/r/n25./r/n關(guān)于簽署知情同意書，下列哪項不正確？/r/nA.受試者在充分了解全部試驗有關(guān)情況后同意并簽字/r/nB.受試者的合法代表了解全部試驗有關(guān)情況后同意并簽字/r/nC/r/n./r/n見證人在見證整個知情過程后，受試者或其合法代表口頭同意，見證人簽字/r/nD/r/n./r/n無行為能力的受試者，必須自愿方可參加試驗/r/n26./r/n以下哪一項不是研究者具備的條件？/r/nA.經(jīng)過本規(guī)范的培訓(xùn)/r/nB/r/n./r/n承擔(dān)該項臨床試驗的專業(yè)特長/r/nC/r/n./r/n完成該項臨床試驗所需的工作時間/r/nD/r/n./r/n承擔(dān)該項臨床試驗的經(jīng)濟能力/r/n27./r/n下列哪個人不需要在知情同意書上簽字？/r/nA.研究者

/r/nB.申辦者代表/r/nC.見證人

D.受試者合法代表/r/n28./r/n下列哪項不是受試者的權(quán)利？/r/nA.自愿參加臨床試驗/r/nB/r/n./r/n自愿退出臨床試驗/r/nC/r/n./r/n選擇進(jìn)入哪一個組別/r/nD/r/n./r/n有充分的時間考慮參加試驗/r/n29./r/n試驗開始前，申辦者和研究者關(guān)于職責(zé)和分工應(yīng)達(dá)成：/r/nA.口頭協(xié)議

/r/nB/r/n./r/n書面協(xié)議/r/nC/r/n./r/n默認(rèn)協(xié)議/r/n

/r/nD/r/n./r/n無需協(xié)議/r/n30./r/n無行為能力的受試者，其知情同意的過程不包括：/r/nA.倫理委員會原則上同意/r/nB/r/n./r/n研究者認(rèn)為參加試驗符合受試者本身利益/r/nC/r/n./r/n研究者可在說明情況后代替受試者或其法定監(jiān)護(hù)人在知情同意書上簽字并注明日期/r/nD/r/n./r/n其法定監(jiān)護(hù)人在知情同意書上簽字并注明簽字日期/r/n31./r/n申/r/n辦/r/n者提供的研究者手冊不包括：/r/nA./r/n試驗/r/n用/r/n藥/r/n的化學(xué)/r/n資/r/n料和數(shù)據(jù)/r/nB./r/n試驗/r/n用/r/n藥/r/n的化學(xué)、/r/n藥/r/n學(xué)/r/n資/r/n料和數(shù)據(jù)/r/nC./r/n試驗/r/n用/r/n藥/r/n的化學(xué)、毒理學(xué)/r/n資/r/n料和數(shù)據(jù)/r/nD./r/n試驗/r/n用/r/n藥/r/n的生/r/n產(chǎn)/r/n工/r/n藝資/r/n料和數(shù)據(jù)/r/n32./r/n敘述/r/n試驗/r/n的背景、理/r/n論/r/n基/r/n礎(chǔ)/r/n和目的、/r/n試驗設(shè)計/r/n、方法和/r/n組織/r/n，包括/r/n統(tǒng)計/r/n學(xué)考/r/n慮/r/n、/r/n試驗執(zhí)/r/n行和完成條件的/r/n臨/r/n床/r/n試驗/r/n的主要文件。/r/nA./r/n知情同意/r/n

B./r/n申/r/n辦/r/n者/r/nC./r/n研究者/r/n

/r/n

D/r/n試驗/r/n方案/r/n33./r/n以下哪一項不是研究者具備的條件？/r/n

/r/nA.承擔(dān)該項臨床試驗的專業(yè)特長/r/nB/r/n./r/n承擔(dān)該項臨床試驗的資格/r/nC/r/n./r/n承擔(dān)該項臨床試驗的所需的人員配備/r/nD/r/n./r/n承擔(dān)該項臨床試驗的組織能力/r/n34./r/n在倫理委員會討論會上，下列什么人能夠參加投票？/r/nA./r/n參見該臨床試驗的委員/r/n

/r/nB非醫(yī)學(xué)專業(yè)委員/r/nC./r/n非委員的專家/r/n

/r/nD/r/n./r/n非委員的稽查人員/r/n35./r/n《/r/n藥/r/n物/r/n臨/r/n床/r/n試驗質(zhì)/r/n量管理/r/n規(guī)/r/n范》何/r/n時/r/n開始施行？/r/n

/r/nA.1998.3

B.1998.6/r/nC.1996.12

/r/nD.2003.9/r/n36./r/n下列哪一項違反倫理委員會的工作程序？/r/nA.接到申請后盡早召開會議/r/nB/r/n./r/n各委員分頭審閱發(fā)表意見/r/nC/r/n./r/n召開審閱討論會議/r/nD/r/n./r/n簽發(fā)書面意見/r/n37./r/n任何在人體/r/n進(jìn)/r/n行的/r/n藥/r/n品的系/r/n統(tǒng)/r/n性研究，以/r/n證實/r/n或揭示/r/n試驗/r/n用/r/n藥/r/n品的作用、不良反/r/n應(yīng)/r/n及/r/n//r/n或研究/r/n藥/r/n品的吸收、分布代/r/n謝/r/n和排泄，目的是確定/r/n試驗/r/n用/r/n藥/r/n品的/r/n療/r/n效和安全性。/r/n

/r/nA./r/n臨/r/n床/r/n試驗/r/n

/r/n

B./r/n臨/r/n床前/r/n試驗/r/nC./r/n倫/r/n理委/r/n員/r/n會/r/n

D./r/n不良事件/r/n38./r/n以下哪一項不是研究者具備的條件？/r/nA.承擔(dān)該項臨床試驗的專業(yè)特長/r/nB/r/n./r/n承擔(dān)該項臨床試驗的資格/r/nC/r/n./r/n承擔(dān)該項臨床試驗的設(shè)備條件/r/nD/r/n./r/n承擔(dān)該項臨床試驗生物統(tǒng)計分析的能力/r/n39./r/n經(jīng)過下列哪項程序，臨床試驗方可實施？/r/nA.向倫理委員會遞交申請/r/nB/r/n./r/n已在倫理委員會備案/r/nC/r/n./r/n試驗方案已經(jīng)倫理委員會口頭同意/r/nD/r/n./r/n試驗方案已經(jīng)倫理委員會同意并簽發(fā)了贊同意見/r/n40./r/n下列哪項不包括在試驗方案內(nèi)？/r/nA.試驗?zāi)康?/p>

B.試驗設(shè)計/r/nC.病例數(shù)

/r/n

/r/nD.受試者受到損害的補償規(guī)定/r/n41./r/n臨/r/n床/r/n試驗/r/n中用于/r/n試驗/r/n或參比的任何/r/n藥/r/n品或安慰/r/n劑/r/n。/r/nA./r/n試驗/r/n用/r/n藥/r/n品/r/n

/r/n

B./r/n藥/r/n品/r/nC./r/n標(biāo)/r/n準(zhǔn)操作/r/n規(guī)/r/n程/r/n

D./r/n藥/r/n品不良反/r/n應(yīng)/r/n42./r/n倫理委員會從下列哪個角度審閱試驗方案？/r/nA.保護(hù)受試者權(quán)益/r/n

/r/nB/r/n./r/n研究的嚴(yán)謹(jǐn)性/r/nC/r/n./r/n主題的先進(jìn)性/r/n

/r/nD/r/n./r/n疾病的危害性/r/n43./r/n倫理委員會書面簽發(fā)其意見時，不需附帶下列哪一項？/r/nA.出席會議的委員名單/r/nB/r/n./r/n出席會議的委員的專業(yè)情況/r/nC/r/n./r/n出席會議委員的研究項目/r/nD/r/n./r/n出席會議委員的簽名/r/n44./r/n下列哪/r/n項/r/n是研究者的/r/n職責(zé)/r/n？/r/nA./r/n任命/r/n監(jiān)查員/r/n，/r/n監(jiān)查臨/r/n床/r/n試驗/r/nB./r/n建立/r/n臨/r/n床/r/n試驗/r/n的/r/n質(zhì)/r/n量控制與/r/n質(zhì)/r/n量保/r/n證/r/n系/r/n統(tǒng)/r/nC./r/n對試驗/r/n用/r/n藥/r/n品作出醫(yī)/r/n療/r/n決定/r/nD./r/n保/r/n證試驗/r/n用/r/n藥/r/n品/r/n質(zhì)/r/n量合格/r/n45./r/n下面哪項不是倫理委員會審閱試驗方案的要點？/r/nA.試驗?zāi)康?r/nB.受試者可能遭受的風(fēng)險及受益/r/nC.臨床試驗的實施計劃/r/nD.試驗設(shè)計的科學(xué)效率/r/n46./r/n下列哪一項不是臨床試驗單位的必備條件？/r/nA.設(shè)施條件必須符合安全有效地進(jìn)行臨床試驗的需要/r/nB/r/n./r/n后勤條件必須符合安全有效地進(jìn)行臨床試驗的需要/r/nC/r/n./r/n三級甲等醫(yī)院/r/nD/r/n./r/n人員條件必須符合安全有效地進(jìn)行臨床試驗的需要/r/n47./r/n保障受試者權(quán)益的主要措施是：/r/nA.有充分的臨床試驗依據(jù)/r/nB/r/n./r/n試驗用藥品的正確使用方法/r/nC/r/n./r/n倫理委員會和知情同意書/r/nD/r/n./r/n保護(hù)受試者身體狀況良好/r/n48./r/n用以保/r/n證/r/n與/r/n臨/r/n床/r/n試驗/r/n相關(guān)活/r/n動/r/n的/r/n質(zhì)/r/n量達(dá)到要求的操作性技/r/n術(shù)/r/n和/r/n規(guī)/r/n程。/r/nA./r/n稽/r/n查/r/n

B./r/n監(jiān)查/r/nC./r/n視/r/n察/r/n

/r/nD./r/n質(zhì)/r/n量控制/r/n49./r/n下列哪項不符合倫理委員會的組成要求？/r/nA.至少有5人組成/r/nB/r/n./r/n至少有一人從事非醫(yī)學(xué)專業(yè)/r/nC/r/n./r/n至少有一人來自其他單位/r/nD/r/n./r/n至少一人接受了本規(guī)范培訓(xùn)/r/n50./r/n在臨床試驗方案中有關(guān)不良反應(yīng)的規(guī)定，下列哪項規(guī)定不正確？/r/nA.不良事件的評定及記錄規(guī)定/r/nB.處理并發(fā)癥措施的規(guī)定/r/nC.對不良事件隨訪的規(guī)定/r/nD.如何快速報告不良事件規(guī)定/r/n二/r/n./r/n判斷/r/n題/r/n(/r/n共/r/n150/r/n題/r/n，共/r/n300/r/n分/r/n)/r/n1./r/n試驗/r/n開始前研究者和申/r/n辦/r/n者關(guān)于/r/n職責(zé)/r/n分工/r/n應(yīng)/r/n達(dá)成口/r/n頭協(xié)議/r/n。（/r/n×/r/n）/r/n2./r/n臨/r/n床/r/n試驗統(tǒng)計報/r/n告必/r/n須/r/n與/r/n臨/r/n床/r/n試驗總結(jié)報/r/n告相符。（/r/n√/r/n）/r/n3./r/n倫/r/n理委/r/n員/r/n會在/r/n簽發(fā)書/r/n面意/r/n見時/r/n只需寫明同意、作必要修改后同意、不同意、/r/n終/r/n止或/r/n暫/r/n停先前已批準(zhǔn)/r/n試驗/r/n的意/r/n見/r/n，不需其他附件。（/r/n×/r/n）/r/n4./r/n《人體生物醫(yī)學(xué)研究的國/r/n際/r/n道德指南》的道德原/r/n則/r/n是公正、尊重人格、力求使受/r/n試/r/n者最大程度受益和盡可能避免/r/n傷/r/n害。（/r/n√/r/n）/r/n5./r/n《/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范》的制定，依據(jù)《中/r/n華/r/n人民共和國/r/n藥/r/n品管理法》，參照國/r/n際/r/n公/r/n認(rèn)/r/n原/r/n則/r/n。（/r/n√/r/n）/r/n

/r/n6./r/n《/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范》/r/n僅/r/n適用人體生物利用度和生物等效性研究。（/r/n×/r/n）/r/n7./r/n在病例/r/n報/r/n告表上作任何更正/r/n時/r/n，/r/n應(yīng)/r/n首先改/r/n變/r/n原始/r/n記錄/r/n，并/r/n說/r/n明理由，且由研究者/r/n簽/r/n字并注明日期。（/r/n×/r/n）/r/n8./r/n倫/r/n理委/r/n員/r/n會在/r/n臨/r/n床/r/n試驗單/r/n位或醫(yī)/r/n療/r/n機構(gòu)內(nèi)建立。（/r/n√/r/n）/r/n9./r/n申/r/n辦/r/n者提供的研究者手冊內(nèi)容/r/n應(yīng)/r/n包括/r/n試驗/r/n用/r/n藥/r/n的化學(xué)、/r/n藥/r/n學(xué)、毒理學(xué)、/r/n藥/r/n理學(xué)和/r/n臨/r/n床的/r/n資/r/n料和數(shù)據(jù)。（/r/n√/r/n）/r/n10./r/n倫/r/n理委/r/n員/r/n會工作的指/r/n導(dǎo)/r/n原/r/n則/r/n之一是《赫/r/n爾/r/n辛基宣言》。（/r/n√/r/n）/r/n11./r/n知情同意/r/n書應(yīng)選/r/n用國/r/n際統(tǒng)/r/n一/r/n規(guī)/r/n定的/r/n語/r/n言和文字。（/r/n×/r/n）/r/n12./r/n監(jiān)查員應(yīng)/r/n在/r/n試驗/r/n前確/r/n認(rèn)試驗/r/n所在/r/n單/r/n位已具/r/n備/r/n所需的/r/n實驗/r/n室/r/n設(shè)備/r/n，并工作良好。（/r/n√/r/n）/r/n13./r/n研究者/r/n應(yīng)/r/n有一份受/r/n試/r/n者的/r/n編碼/r/n和確/r/n認(rèn)記錄/r/n，在/r/n試驗結(jié)/r/n束后方可公布。（/r/n×/r/n）/r/n14./r/n在多中心臨床試驗中應(yīng)加強監(jiān)查員的職能。/r/n（/r/n√）/r/n15./r/n研究者/r/n應(yīng)讓/r/n盡量多的受/r/n試/r/n者/r/n進(jìn)/r/n入/r/n試驗/r/n。（/r/n×/r/n）/r/n16./r/n設(shè)/r/n盲的/r/n臨/r/n床/r/n試驗/r/n因隨機分/r/n組/r/n，故不需做可比性比/r/n較/r/n。（/r/n×/r/n）/r/n17./r/n多中心臨床試驗應(yīng)根據(jù)同一試驗方案培訓(xùn)參加該試驗的研究者。/r/n（/r/n√）/r/n18./r/n除無行/r/n為/r/n能力的人，所有受/r/n試/r/n者都必/r/n須/r/n是自愿參加/r/n試驗/r/n。（/r/n√/r/n）/r/n19./r/n研究者提前/r/n終/r/n止或/r/n暫/r/n停一/r/n項臨/r/n床/r/n試驗/r/n，可根據(jù)具體情況決定是否通知/r/n倫/r/n理委/r/n員/r/n會。（/r/n×/r/n）/r/n20./r/n申/r/n辦/r/n者/r/n應(yīng)/r/n及/r/n時/r/n向/r/n倫/r/n理委/r/n員/r/n會提交/r/n臨/r/n床/r/n試驗/r/n方案，/r/n請/r/n求批準(zhǔn)。（/r/n×/r/n）/r/n21./r/n臨/r/n床/r/n試驗/r/n前/r/n對臨/r/n床/r/n試驗/r/n方案/r/n進(jìn)/r/n行/r/n審閱/r/n是/r/n倫/r/n理委/r/n員/r/n會的/r/n職責(zé)/r/n。（/r/n√/r/n）/r/n22./r/n臨/r/n床/r/n試驗/r/n方案中/r/n試驗設(shè)計/r/n包括/r/n對/r/n照或開放、平行或交叉、雙盲或/r/n單/r/n盲、隨機化方法與步/r/n驟/r/n、/r/n單/r/n中心與多中心。（/r/n√/r/n）/r/n23./r/n申/r/n辦/r/n者及研究者均/r/n應(yīng)/r/n采用/r/n標(biāo)/r/n準(zhǔn)操作程序的方式/r/n執(zhí)/r/n行/r/n臨/r/n床/r/n試驗/r/n的/r/n質(zhì)/r/n量控制和/r/n質(zhì)/r/n量保/r/n證/r/n系/r/n統(tǒng)/r/n。（/r/n√/r/n）/r/n24./r/n每一受/r/n試/r/n者在/r/n試驗/r/n中的有關(guān)/r/n資/r/n料只/r/n記錄/r/n在病/r/n歷/r/n中。（/r/n×/r/n）/r/n25./r/n監(jiān)查員在試驗前、中、后期訪視試驗承擔(dān)單位和研究者，確保病例報告表中所有數(shù)據(jù)無一缺失。（×）/r/n26./r/n臨/r/n床/r/n試驗/r/n數(shù)據(jù)/r/n統(tǒng)計/r/n分析/r/n結(jié)/r/n果的表達(dá)著重在/r/n臨/r/n床意/r/n義/r/n的理解，/r/n對/r/n治/r/n療/r/n作用的/r/n評/r/n價/r/n應(yīng)/r/n將可信限的差/r/n別/r/n與/r/n顯/r/n著性/r/n檢驗/r/n的/r/n結(jié)/r/n果一并予以考/r/n慮/r/n，而不一定依/r/n賴/r/n于/r/n顯/r/n著性/r/n檢驗/r/n。（/r/n√/r/n）/r/n27./r/n監(jiān)查員應(yīng)/r/n確/r/n認(rèn)/r/n所有不良事件已在/r/n試驗結(jié)/r/n束前作出/r/n報/r/n告并/r/n記錄/r/n在案。（/r/n×/r/n）/r/n28./r/n一般人只要/r/n經(jīng)過/r/n適當(dāng)/r/n訓(xùn)練/r/n即可/r/n監(jiān)查臨/r/n床/r/n試驗/r/n。（/r/n×/r/n）/r/n29./r/n倫/r/n理委/r/n員/r/n會的工作/r/n記錄/r/n要保持到/r/n試驗結(jié)/r/n束后/r/n2/r/n年。（/r/n×/r/n）/r/n30./r/n在/r/n臨/r/n床/r/n試驗過/r/n程中/r/n發(fā)/r/n生的不良事件若可能與/r/n試驗藥/r/n品無關(guān)，/r/n則/r/n研究者可不做/r/n記錄/r/n和/r/n報/r/n告。（/r/n×/r/n）/r/n31./r/n《/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范》是有關(guān)/r/n臨/r/n床/r/n試驗/r/n全/r/n過/r/n程的/r/n標(biāo)/r/n準(zhǔn)/r/n規(guī)/r/n定，包括方案/r/n設(shè)計/r/n、/r/n組織/r/n、/r/n實/r/n施、/r/n監(jiān)查/r/n、稽/r/n查/r/n、/r/n記錄/r/n、分析、/r/n總結(jié)/r/n和/r/n報/r/n告的方法。（/r/n√/r/n）/r/n

/r/n32./r/n凡新/r/n藥臨/r/n床/r/n試驗/r/n或人體生物學(xué)研究/r/n實/r/n施前均需/r/n經(jīng)藥/r/n政管理機構(gòu)批準(zhǔn)。（/r/n√/r/n）/r/n33./r/n研究者不遵從方案、/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范或法/r/n規(guī)進(jìn)/r/n行/r/n臨/r/n床/r/n試驗時/r/n，申/r/n辦/r/n者/r/n應(yīng)/r/n指出以求/r/n糾/r/n正，如情況/r/n嚴(yán)/r/n重或持/r/n續(xù)/r/n不遵從/r/n則應(yīng)/r/n向/r/n藥/r/n政管理部/r/n門報/r/n告，但無/r/n權(quán)/r/n中止研究者/r/n繼續(xù)臨/r/n床/r/n試驗/r/n。（/r/n×/r/n）/r/n34./r/n臨/r/n床/r/n試驗/r/n方案中/r/n應(yīng)/r/n包括/r/n評/r/n價/r/n試驗結(jié)/r/n果采用的方法和必要/r/n時/r/n從/r/n總結(jié)報/r/n告中剔除病例的依據(jù)。（/r/n×/r/n）/r/n35./r/n申/r/n辦/r/n者向研究者提供具有易于/r/n識別/r/n、正確/r/n編碼/r/n、并/r/n貼/r/n有特殊/r/n標(biāo)簽/r/n的/r/n試驗/r/n用/r/n藥/r/n品。（/r/n√/r/n）/r/n36./r/n倫/r/n理委/r/n員/r/n會/r/n簽發(fā)/r/n的意/r/n見/r/n可以是同意、作必要修改后同意、不同意、/r/n終/r/n止或/r/n暫/r/n停先前已批準(zhǔn)的/r/n試驗/r/n。（/r/n√/r/n）/r/n37./r/n研究者必/r/n須/r/n在合法的醫(yī)/r/n療/r/n機構(gòu)中具有中/r/n級/r/n以上/r/n職/r/n稱。（/r/n×/r/n）/r/n38./r/n申/r/n辦/r/n者/r/n應(yīng)/r/n保存/r/n臨/r/n床/r/n試驗資/r/n料，保存期/r/n為臨/r/n床/r/n試驗結(jié)/r/n束后至少/r/n2/r/n年。（/r/n×/r/n）/r/n39./r/n多中心/r/n臨/r/n床/r/n試驗實/r/n施/r/n計/r/n劃中/r/n應(yīng)/r/n考/r/n慮/r/n在/r/n試驗/r/n中期/r/n組織/r/n召開研究會/r/n議/r/n。（/r/n√/r/n）/r/n40./r/n倫/r/n理委/r/n員/r/n會最多由/r/n5/r/n人/r/n組/r/n成。（/r/n×/r/n）/r/n41./r/n臨/r/n床/r/n試驗/r/n方案批準(zhǔn)后，在/r/n臨/r/n床/r/n試驗過/r/n程中的修改可不/r/n報/r/n告/r/n倫/r/n理委/r/n員/r/n會。（/r/n×/r/n）/r/n42./r/n研究者所有的/r/n試驗藥/r/n品/r/n應(yīng)/r/n用于/r/n該藥/r/n品/r/n臨/r/n床/r/n試驗/r/n的受/r/n試/r/n者，但/r/n對/r/n于希望使用/r/n該藥/r/n品的未入/r/n選試驗/r/n的患者，可在研究者/r/n監(jiān)護(hù)/r/n下使用/r/n該藥/r/n。（/r/n×/r/n）/r/n43./r/n申/r/n辦/r/n者/r/n應(yīng)/r/n保存/r/n臨/r/n床/r/n試驗資/r/n料，保存期/r/n為臨/r/n床/r/n試驗結(jié)/r/n束后至少/r/n3/r/n年。（/r/n×/r/n）/r/n44./r/n在/r/n設(shè)/r/n盲的/r/n試驗/r/n中/r/n應(yīng)/r/n在方案中表明破盲的條件和/r/n執(zhí)/r/n行破盲的人/r/n員/r/n。（/r/n√/r/n）/r/n45./r/n如/r/n發(fā)現(xiàn)/r/n涉及/r/n試驗藥/r/n品的重要新/r/n資/r/n料有必要再次取得受/r/n試/r/n者同意，/r/n則/r/n必/r/n須/r/n將知情同意/r/n書/r/n作出/r/n書/r/n面修改，送/r/n倫/r/n理委/r/n員/r/n會批準(zhǔn)后，再征得受/r/n試/r/n者同意。（/r/n√/r/n）/r/n46./r/n臨/r/n床/r/n試驗/r/n中/r/n進(jìn)/r/n行/r/n監(jiān)查/r/n的目的之一是/r/n證實試驗/r/n的/r/n進(jìn)/r/n行遵循已批準(zhǔn)的方案。（/r/n√/r/n）/r/n47./r/n倫/r/n理委/r/n員/r/n會要/r/n對/r/n申/r/n辦/r/n者的/r/n資/r/n格/r/n進(jìn)/r/n行稽/r/n查/r/n。（/r/n×/r/n）/r/n48./r/n臨/r/n床/r/n試驗/r/n方案中/r/n應(yīng)/r/n包括不良事件的/r/n評/r/n定/r/n記錄/r/n和/r/n報/r/n告方法，/r/n處/r/n理并/r/n發(fā)/r/n癥的措施以及事后隨/r/n訪/r/n的方式和/r/n時間/r/n。（/r/n×/r/n）/r/n49./r/n在/r/n臨/r/n床/r/n試驗/r/n數(shù)據(jù)的/r/n統(tǒng)計/r/n分析中/r/n發(fā)現(xiàn)/r/n有/r/n遺/r/n漏、未用或多余的/r/n資/r/n料可不必加以/r/n說/r/n明。（/r/n×/r/n）/r/n50./r/n所有參加/r/n臨/r/n床/r/n試驗/r/n的人/r/n員/r/n必/r/n須/r/n熟悉和/r/n執(zhí)/r/n行本/r/n規(guī)/r/n范。（/r/n×/r/n）/r/n51./r/n臨/r/n床/r/n試驗/r/n中/r/n進(jìn)/r/n行/r/n監(jiān)查/r/n的目的之一是/r/n證實試驗/r/n中/r/n報/r/n告的數(shù)據(jù)準(zhǔn)確、完整無/r/n誤/r/n。（/r/n√/r/n）/r/n52./r/n監(jiān)查員/r/n每次/r/n訪視/r/n后，向研究者/r/n遞/r/n交的/r/n報/r/n告/r/n應(yīng)/r/n述明/r/n訪問/r/n日期、/r/n時間/r/n、/r/n監(jiān)查/r/n者姓名、/r/n訪視/r/n的/r/n發(fā)現(xiàn)/r/n以及/r/n對錯/r/n漏作出的/r/n糾/r/n正。（/r/n×/r/n）/r/n53./r/n監(jiān)查員應(yīng)/r/n在每次/r/n訪視時/r/n，確/r/n認(rèn)/r/n已有的/r/n錯誤/r/n或/r/n遺/r/n漏均已改正或注明，/r/n經(jīng)/r/n受/r/n試/r/n者/r/n簽/r/n名并注明日期。（/r/n×/r/n）/r/n54./r/n為/r/n保/r/n證/r/n數(shù)據(jù)/r/n錄/r/n入的準(zhǔn)確，/r/n應(yīng)/r/n由技/r/n術(shù)/r/n熟/r/n練/r/n的同一/r/n錄/r/n入人/r/n員/r/n分二次完成/r/n錄/r/n入。（/r/n×/r/n）/r/n55./r/n已知/r/n對/r/n人體的可能危/r/n險/r/n性和受益/r/n應(yīng)/r/n在知情同意/r/n書/r/n中/r/n詳細(xì)/r/n寫明，/r/n臨/r/n床/r/n試驗/r/n方案不包括/r/n這/r/n一/r/n項/r/n內(nèi)容。（/r/n×/r/n）/r/n56./r/n申/r/n辦/r/n者不/r/n負(fù)責(zé)/r/n建立/r/n試驗/r/n用/r/n藥/r/n品的登/r/n記/r/n、保管、分/r/n發(fā)/r/n管理制度和/r/n記錄/r/n系/r/n統(tǒng)/r/n。（/r/n×/r/n）/r/n57./r/n研究者/r/n應(yīng)/r/n將/r/n臨/r/n床/r/n試驗/r/n的/r/n資/r/n料在醫(yī)/r/n療單/r/n位保存，保存期/r/n為試驗藥/r/n品/r/n臨/r/n床/r/n試驗結(jié)/r/n束后至少/r/n3/r/n年。（/r/n×/r/n）/r/n58./r/n病例/r/n報/r/n告表是/r/n臨/r/n床/r/n試驗/r/n中/r/n臨/r/n床/r/n資/r/n料的/r/n記錄/r/n方式。（/r/n√/r/n）/r/n59./r/n為/r/n保/r/n證/r/n數(shù)據(jù)/r/n錄/r/n入的準(zhǔn)確，/r/n應(yīng)/r/n采用二次/r/n錄/r/n入法或校/r/n對/r/n法。（/r/n√/r/n）/r/n60./r/n保/r/n證臨/r/n床/r/n試驗/r/n的/r/n進(jìn)/r/n展是研究者/r/n職責(zé)/r/n，與/r/n監(jiān)查員/r/n無關(guān)。（/r/n×/r/n）/r/n61./r/n研究者在/r/n臨/r/n床/r/n試驗/r/n開始后，按/r/n臨/r/n床/r/n試驗/r/n的具體情況決定/r/n記錄/r/n數(shù)據(jù)的方式。（/r/n×/r/n）/r/n62./r/n倫/r/n理委/r/n員/r/n會主要從保/r/n護(hù)/r/n受/r/n試/r/n者/r/n權(quán)/r/n益的角度/r/n審閱試驗/r/n方案，不包括/r/n對/r/n研究者/r/n資/r/n格的稽/r/n查/r/n。（/r/n×/r/n）/r/n63./r/n應(yīng)/r/n使用/r/n計/r/n算機數(shù)據(jù)的/r/n質(zhì)/r/n量控制程序，將/r/n遺/r/n漏的和不準(zhǔn)確的數(shù)據(jù)所引起的影響降低到最低程度。（/r/n√/r/n）/r/n64./r/n研究者根據(jù)有關(guān)/r/n資/r/n料起草/r/n臨/r/n床/r/n試驗/r/n方案并/r/n簽/r/n字后即可/r/n實/r/n施。（/r/n×/r/n）/r/n65./r/n在病例/r/n報/r/n告表上作任何更正/r/n時/r/n，不得改/r/n變/r/n原始/r/n記錄/r/n，只能采用附加敘述并/r/n說/r/n明理由，并由更正的研究者/r/n簽/r/n字和注明日期。（/r/n√/r/n）/r/n66./r/n在/r/n試驗過/r/n程中，數(shù)據(jù)的登/r/n記應(yīng)/r/n具有/r/n連續(xù)/r/n性。（/r/n√/r/n）/r/n67./r/n臨/r/n床/r/n試驗/r/n方案/r/n應(yīng)/r/n包括非/r/n臨/r/n床研究中有意/r/n義/r/n的/r/n發(fā)現(xiàn)/r/n和與/r/n試驗/r/n有關(guān)的/r/n臨/r/n床/r/n試驗發(fā)現(xiàn)/r/n。（/r/n√/r/n）/r/n68./r/n倫/r/n理委/r/n員/r/n會獨立工作不受任何參/r/n試/r/n者的影響。（/r/n√/r/n）/r/n69./r/n監(jiān)查員應(yīng)/r/n核/r/n實試驗/r/n用/r/n藥/r/n品是否按照/r/n藥/r/n品管理法/r/n規(guī)進(jìn)/r/n行供/r/n應(yīng)/r/n、/r/n儲/r/n藏、分/r/n發(fā)/r/n、回收和有相/r/n應(yīng)/r/n的/r/n記錄/r/n，并/r/n證實該過/r/n程是否安全可靠。（/r/n√/r/n）/r/n70./r/n不良事件的隨/r/n訪/r/n及醫(yī)/r/n療/r/n措施在/r/n試驗結(jié)/r/n束/r/n時/r/n同/r/n時結(jié)/r/n束。（/r/n×/r/n）/r/n71./r/n在多中心/r/n試驗/r/n中/r/n評/r/n價/r/n療/r/n效/r/n時/r/n，/r/n應(yīng)/r/n考/r/n慮/r/n中心/r/n間/r/n存在的差異及其影響。（/r/n√/r/n）/r/n72./r/n臨/r/n床/r/n試驗總結(jié)報/r/n告的內(nèi)容/r/n應(yīng)/r/n只/r/n報/r/n告隨機/r/n進(jìn)/r/n入治/r/n療組/r/n的完成病例數(shù)，中途剔除的病例，因未完成/r/n試驗/r/n不必/r/n進(jìn)/r/n行分析。（/r/n×/r/n）/r/n73./r/n臨/r/n床/r/n試驗/r/n方案中/r/n應(yīng)/r/n包括/r/n試驗/r/n用/r/n藥/r/n、安慰/r/n劑/r/n和/r/n對/r/n照/r/n藥/r/n的登/r/n記/r/n和/r/n記錄/r/n制度（/r/n√/r/n）/r/n74./r/n多中心/r/n臨/r/n床/r/n試驗/r/n要求同/r/n時/r/n開始，但可以不同/r/n時結(jié)/r/n束。（/r/n×/r/n）/r/n75./r/n監(jiān)查員職責(zé)/r/n之一是督促/r/n臨/r/n床/r/n試驗/r/n的/r/n進(jìn)/r/n行與/r/n發(fā)/r/n展。（/r/n√/r/n）/r/n76./r/n對顯/r/n著偏離或/r/n臨/r/n床可接受范/r/n圍/r/n以外的數(shù)據(jù)/r/n須/r/n加以核/r/n實/r/n，由研究者作必要的/r/n說/r/n明。（/r/n√/r/n）/r/n77./r/n臨/r/n床/r/n試驗/r/n中隨機分配受/r/n試/r/n者只需/r/n嚴(yán)/r/n格按/r/n試驗/r/n方案的/r/n設(shè)計/r/n步/r/n驟執(zhí)/r/n行，不必另外/r/n記錄/r/n。（/r/n×/r/n）/r/n78./r/n如/r/n發(fā)現(xiàn)/r/n涉及/r/n試驗藥/r/n品的重要新/r/n資/r/n料有必要再次取得受/r/n試/r/n者同意，/r/n則/r/n必/r/n須/r/n將知情同意/r/n書/r/n作出/r/n書/r/n面修改，再征得受/r/n試/r/n者同意。（/r/n×/r/n）/r/n79./r/n《藥品臨床試驗管理規(guī)范》的目的之一是使藥品臨床試驗達(dá)到預(yù)期的治療效果。/r/n（/r/n×）/r/n80./r/n倫/r/n理委/r/n員/r/n會中參加本/r/n臨/r/n床/r/n試驗/r/n的委/r/n員/r/n不投票。（/r/n√/r/n）/r/n81./r/n臨/r/n床/r/n試驗/r/n中/r/n進(jìn)/r/n行/r/n監(jiān)查/r/n的目的之一是/r/n證實試驗/r/n的/r/n進(jìn)/r/n行遵循/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范和有關(guān)法/r/n規(guī)/r/n。（/r/n√/r/n）/r/n82./r/n研究者/r/n應(yīng)/r/n接受/r/n監(jiān)查員/r/n的定期/r/n訪問/r/n和主管部/r/n門/r/n的稽/r/n查/r/n和/r/n視/r/n察。（/r/n√/r/n）/r/n83./r/n在/r/n臨/r/n床/r/n試驗/r/n開始前，研究者和申/r/n辦/r/n者/r/n應(yīng)/r/n就/r/n試驗/r/n方案、/r/n試驗/r/n的/r/n監(jiān)查/r/n、稽/r/n查/r/n和/r/n標(biāo)/r/n準(zhǔn)操作/r/n規(guī)/r/n程以及/r/n職責(zé)/r/n分工等達(dá)成/r/n書/r/n面/r/n協(xié)議/r/n。（/r/n√/r/n）/r/n84./r/n數(shù)據(jù)/r/n處/r/n理、/r/n統(tǒng)計/r/n分析、/r/n結(jié)/r/n果/r/n報/r/n告、/r/n發(fā)/r/n表方式等均屬研究者/r/n職責(zé)/r/n，不/r/n須/r/n另外分工。（/r/n×/r/n）/r/n85./r/n研究者/r/n應(yīng)/r/n向受/r/n試/r/n者/r/n說/r/n明有關(guān)/r/n試驗/r/n的/r/n詳細(xì)/r/n情況，并在受/r/n試/r/n者或其法定/r/n監(jiān)護(hù)/r/n人同意并/r/n簽/r/n字后取得知情同意/r/n書/r/n。（/r/n√/r/n）/r/n86./r/n監(jiān)查員/r/n需在/r/n試驗/r/n前確/r/n認(rèn)試驗/r/n所在/r/n單/r/n位是否已具/r/n備試驗/r/n所需的/r/n實驗/r/n室/r/n設(shè)備/r/n。（/r/n√/r/n）/r/n87./r/n研究者/r/n應(yīng)/r/n將/r/n臨/r/n床/r/n試驗/r/n的/r/n資/r/n料在所在醫(yī)/r/n療單/r/n位保存，保存期/r/n為試驗藥/r/n品/r/n臨/r/n床/r/n試驗結(jié)/r/n束后至少/r/n5/r/n年。（/r/n√/r/n）/r/n88./r/n研究者/r/n應(yīng)/r/n在合法的醫(yī)/r/n療/r/n機構(gòu)中具有任/r/n職/r/n行醫(yī)的/r/n資/r/n格。（/r/n√/r/n）/r/n89./r/n建立適當(dāng)?shù)?r/n標(biāo)/r/n準(zhǔn)操作/r/n規(guī)/r/n程，防止未/r/n經(jīng)/r/n申/r/n辦/r/n者授/r/n權(quán)/r/n的人接觸數(shù)據(jù)，以保/r/n證/r/n數(shù)據(jù)/r/n庫/r/n的保密性。（/r/n√/r/n）/r/n90./r/n臨/r/n床/r/n試驗總結(jié)報/r/n告/r/n應(yīng)/r/n與/r/n臨/r/n床/r/n試驗/r/n方案一致。（/r/n√/r/n）/r/n91./r/n《/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范》適用于所有新/r/n藥臨/r/n床前/r/n試驗/r/n。（/r/n×/r/n）/r/n92./r/n臨/r/n床/r/n試驗/r/n方案/r/n應(yīng)/r/n包括/r/n試驗預(yù)/r/n期的/r/n進(jìn)/r/n度和完成日期。（/r/n√/r/n）/r/n93./r/n臨/r/n床/r/n試驗/r/n方案/r/n應(yīng)/r/n包括已知/r/n對/r/n人體的可能危/r/n險/r/n性和受益。（/r/n√/r/n）/r/n94./r/n申/r/n辦/r/n者在/r/n獲/r/n得/r/n藥/r/n政管理部/r/n門/r/n批準(zhǔn)后即可開始按方案和本/r/n規(guī)/r/n范原/r/n則組織臨/r/n床/r/n試驗/r/n。（/r/n×/r/n）/r/n95./r/n研究者提前/r/n終/r/n止或/r/n暫/r/n停一/r/n項臨/r/n床/r/n試驗時/r/n，必/r/n須/r/n事先通知受/r/n試/r/n者、/r/n藥/r/n政管理部/r/n門/r/n、申/r/n辦/r/n者和/r/n倫/r/n理委/r/n員/r/n會，并述明理由。（/r/n×/r/n）/r/n96./r/n研究者如有適當(dāng)理由可不接受/r/n監(jiān)查員/r/n的定期/r/n訪問/r/n和主管部/r/n門/r/n的稽/r/n查/r/n和/r/n視/r/n察。（/r/n×/r/n）/r/n97./r/n監(jiān)查員應(yīng)/r/n在每次/r/n訪視時/r/n，如確/r/n認(rèn)/r/n所有病例/r/n報/r/n告表填寫清楚、完整，/r/n則/r/n不需與原始/r/n資/r/n料核/r/n對/r/n。（/r/n×/r/n）/r/n98./r/n在/r/n臨/r/n床/r/n試驗總結(jié)報/r/n告中，/r/n應(yīng)/r/n用/r/n圖/r/n、表、/r/n試驗/r/n參數(shù)和/r/nP/r/n值/r/n表達(dá)各治/r/n療組/r/n的有效性和安全性。（/r/n×/r/n）/r/n99./r/n臨/r/n床/r/n試驗/r/n方案中因包括/r/n臨/r/n床/r/n觀/r/n察及/r/n實驗/r/n室/r/n檢查/r/n的/r/n項/r/n目和/r/n測/r/n定次數(shù)以及隨/r/n訪/r/n步/r/n驟/r/n。（/r/n√/r/n）/r/n100./r/n臨/r/n床/r/n試驗/r/n方案需/r/n經(jīng)倫/r/n理委/r/n員/r/n會同意并/r/n簽發(fā)贊/r/n同意/r/n見/r/n后方可/r/n實/r/n施。（/r/n√/r/n）/r/n101./r/n在/r/n臨/r/n床/r/n試驗過/r/n程中如/r/n發(fā)/r/n生不良事件，研究者/r/n應(yīng)/r/n立即/r/n對/r/n受/r/n試/r/n者采取適當(dāng)?shù)谋?r/n護(hù)/r/n措施。并同/r/n時報/r/n告/r/n藥/r/n政管理部/r/n門/r/n、申/r/n辦/r/n者和/r/n倫/r/n理委/r/n員/r/n會，且在/r/n報/r/n告上/r/n簽/r/n名、注明日期。（/r/n×/r/n）/r/n102./r/n臨/r/n床/r/n試驗/r/n完成后，研究者必/r/n須/r/n寫出/r/n總結(jié)報/r/n告、/r/n簽/r/n名并注明日期，送交申/r/n辦/r/n者。（/r/n√/r/n）/r/n103./r/n臨/r/n床/r/n試驗/r/n中/r/n進(jìn)/r/n行/r/n監(jiān)查/r/n的目的之一是/r/n證實試驗/r/n遵循的方案的科學(xué)性。（/r/n√/r/n）/r/n104./r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n必/r/n須/r/n遵循道德原/r/n則/r/n。（/r/n√/r/n）/r/n105./r/n臨/r/n床/r/n試驗總結(jié)報/r/n告的內(nèi)容/r/n應(yīng)/r/n包括不同治/r/n療組/r/n的基本情況比/r/n較/r/n，以確定可比性。（/r/n√/r/n）/r/n106./r/n研究者不遵從方案、/r/n藥/r/n品/r/n臨/r/n床/r/n試驗/r/n管理/r/n規(guī)/r/n范或法/r/n規(guī)進(jìn)/r/n行/r/n臨/r/n床/r/n試驗時/r/n，申/r/n辦/r/n者/r/n應(yīng)/r/n指出以求/r/n糾/r/n正，如情況/r/n嚴(yán)/r/n重或持/r/n續(xù)/r/n不遵從/r/n則應(yīng)/r/n中止研究者/r/n進(jìn)/r/n行/r/n臨/r/n床/r/n試驗/r/n并向/r/n藥/r/n政管理部/r/n門報/r/n告。（/r/n√/r/n）/r/n107./r/n研究者必/r/n須/r/n保/r/n證/r/n所有/r/n試驗藥/r/n品/r/n僅/r/n用于/r/n該臨/r/n床/r/n試驗/r/n的受/r/n試/r/n者，其/r/n劑/r/n量與用法/r/n應(yīng)/r/n遵照/r/n試驗/r/n方案，剩余的/r/n試驗藥/r/n品退回申/r/n辦/r/n者，整個/r/n過/r/n程需由/r/n專/r/n人/r/n負(fù)責(zé)/r/n并/r/n記錄/r/n在案。（/r/n√/r/n）/r/n108./r/n倫/r/n理委/r/n員/r/n會不需要/r/n對試驗設(shè)計/r/n的科學(xué)效率/r/n進(jìn)/r/n行/r/n審閱/r/n。（/r/n×/r/n）/r/n109./r/n多中心/r/n臨/r/n床/r/n試驗/r/n方案及附件由主要研究者起草后/r/n經(jīng)/r/n申/r/n辦/r/n者同意，/r/n倫/r/n理委/r/n員/r/n會批準(zhǔn)后/r/n執(zhí)/r/n行。（/r/n×/r/n）/r/n110./r/n倫/r/n理委/r/n員/r/n會要/r/n對/r/n研究者的/r/n資/r/n格/r/n進(jìn)/r/n行/r/n審查/r/n。（/r/n√/r/n）/r/n111./r/n研究者/r/n應(yīng)/r/n將/r/n臨/r/n床/r/n試驗/r/n的/r/n資/r/n料在所在醫(yī)/r/n療單/r/n位保存，保存期/r/n為藥/r/n品被上市后至少/r/n3/r/n年。（/r/n×/r/n）/r/n112./r/n監(jiān)查員/r/n每次/r/n訪視時/r/n，/r/n應(yīng)/r/n在確/r/n認(rèn)/r/n所有的/r/n錯誤/r/n或/r/n遺/r/n漏均已修改后，在病例/r/n報/r/n告上/r/n簽/r/n字。（/r/n×/r/n）/r/n113./r/n參加國/r/n際/r/n多中心/r/n臨/r/n床/r/n試驗/r/n的人/r/n員/r/n只受國/r/n際/r/n公/r/n認(rèn)/r/n原/r/n則/r/n的/r/n約/r/n束。（/r/n×/r/n）/r/n114./r/n倫/r/n理委/r/n員/r/n會的工作受中國有關(guān)法律法/r/n規(guī)/r/n的/r/n約/r/n束。（/r/n√/r/n）/r/n115./r/n倫/r/n理委/r/n員/r/n會中被邀/r/n請/r/n的非委/r/n員專/r/n家也可以參加投票。（/r/n×/r/n）/r/n116./r/n臨/r/n床/r/n試驗設(shè)計/r/n的科學(xué)效率是以最小受/r/n試/r/n者/r/n樣/r/n本數(shù)/r/n獲/r/n得正確/r/n結(jié)/r/n果的可能性。（/r/n√/r/n）/r/n117./r/n臨/r/n床/r/n試驗/r/n的/r/n設(shè)計/r/n與/r/n結(jié)/r/n果的表達(dá)及分析/r/n過/r/n程中，必/r/n須/r/n采用公/r/n認(rèn)/r/n的/r/n統(tǒng)計/r/n分析方法，并/r/n應(yīng)貫徹/r/n于/r/n臨/r/n床/r/n試驗/r/n的始/r/n終/r/n。（/r/n√/r/n）/r/n118./r/n在數(shù)據(jù)/r/n處/r/n理、/r/n統(tǒng)計/r/n分析、/r/n結(jié)/r/n果/r/n報/r/n告、/r/n發(fā)/r/n表方式等方面研究者與申/r/n辦/r/n者/r/n應(yīng)協(xié)議/r/n分工。（/r/n√/r/n）/r/n119./r/n監(jiān)查員/r/n在/r/n試驗/r/n中/r/n訪視試驗/r/n承擔(dān)/r/n單/r/n位和研究者，以求所有受/r/n試/r/n者在/r/n試驗/r/n完成前取得了知情同意/r/n書/r/n。（/r/n×/r/n）/r/n120./r/n多中心臨床試驗在各中心根據(jù)各自具體情況管理藥品，包括分發(fā)和儲藏。/r/n（/r/n×）/r/n121./r/n多中心臨床試驗的數(shù)據(jù)資料應(yīng)集中管理與分析，并建立數(shù)據(jù)傳遞與查詢程序。/r/n（/r/n√）/r/n122./r/n臨/r/n床/r/n試驗/r/n數(shù)據(jù)管理的各種步/r/n驟/r/n均/r/n應(yīng)記錄/r/n在案，以便/r/n對/r/n數(shù)據(jù)/r/n質(zhì)/r/n量及/r/n試驗實/r/n施作/r/n檢查/r/n。（/r/n√/r/n）/r/n123./r/n臨/r/n床/r/n試驗/r/n方案中/r/n應(yīng)/r/n根據(jù)/r/n藥/r/n效與/r/n藥/r/n代/r/n動/r/n力學(xué)研究/r/n結(jié)/r/n果及量效關(guān)系制定/r/n試驗藥/r/n與/r/n對/r/n照/r/n藥/r/n的/r/n給藥/r/n途徑、/r/n劑/r/n量、/r/n給藥/r/n次數(shù)和有關(guān)合并用/r/n藥/r/n的/r/n規(guī)/r/n定。（/r/n√/r/n）/r/n124./r/n監(jiān)查員/r/n可根據(jù)研究者提供的信息，確/r/n認(rèn)試驗/r/n所在/r/n單/r/n位是否具/r/n備/r/n了適當(dāng)?shù)臈l件。（/r/n×/r/n）/r/n125./r/n各種/r/n實驗/r/n室數(shù)據(jù)均/r/n應(yīng)記錄/r/n或?qū)⒃?r/n報/r/n告粘/r/n貼/r/n在病例/r/n報/r/n告表上，在正常范/r/n圍/r/n的數(shù)據(jù)也/r/n應(yīng)記錄/r/n。（/r/n√/r/n）/r/n126./r/n在/r/n試驗過/r/n程中，數(shù)據(jù)的登/r/n記/r/n不一定要具有/r/n連續(xù)/r/n性。（/r/n×/r/n）/r/n127./r/n臨/r/n床/r/n試驗/r/n方案/r/n應(yīng)/r/n包括/r/n臨/r/n床/r/n試驗/r/n的/r/n題/r/n目和立/r/n題/r/n的理由。（/r/n√/r/n）/r/n128./r/n研究者提前/r/n終/r/n止或/r/n暫/r/n停一/r/n項臨/r/n床/r/n試驗/r/n必/r/n須/r/n通知受/r/n試/r/n者、/r/n藥/r/n政管理部/r/n門/r/n、申/r/n辦/r/n者和/r/n倫/r/n理委/r/n員/r/n會，并述明理由。（/r/n√/r/n）/r/n129./r/n倫/r/n理委/r/n員/r/n會在/r/n討論/r/n后以投票方式/r/n對審查/r/n意/r/n見/r/n做出決定。（/r/n√/r/n）/r/n130./r/n多中心/r/n臨/r/n床/r/n試驗/r/n由申/r/n辦/r/n者/r/n總負(fù)責(zé)/r/n，并作/r/n為臨/r/n床/r/n試驗/r/n各中心/r/n間/r/n的/r/n協(xié)調(diào)/r/n人。（/r/n×/r/n）/r/n131./r/n研究者/r/n應(yīng)獲/r/n得所在/r/n單/r/n位的同意，保/r/n證/r/n有充分的/r/n時間/r/n在方案所/r/n規(guī)/r/n定的期限內(nèi)/r/n負(fù)責(zé)/r/n和完成/r/n臨/r/n床/r/n試驗/r/n。（/r/n√/r/n）/r/n132./r/n在雙盲/r/n臨/r/n床/r/n試驗/r/n中，研究中的/r/n藥/r/n品與/r/n對/r/n照/r/n藥/r/n品或安慰/r/n劑/r/n在外形、氣味、包裝、/r/n標(biāo)簽/r/n和其他特征上均/r/n應(yīng)/r/n一致。（/r/n√/r/n）/r/n133./r/n在數(shù)據(jù)/r/n處/r/n理中必要/r/n時須/r/n采用/r/n質(zhì)/r/n量控制，以保/r/n證/r/n所有數(shù)據(jù)可靠，/r/n處/r/n理正確。（/r/n×/r/n）/r/n134./r/n申辦者及研究者均應(yīng)采用認(rèn)真工作的方式來保證臨床試驗的質(zhì)量。（×）/r/n135./r/n試驗/r/n用/r/n藥/r/n品不得在市/r/n場/r/n上/r/n銷/r/n售。（/r/n√/r/n）/r/n136./r/n在雙盲/r/n臨/r/n床/r/n試驗/r/n中，研究中的/r/n藥/r/n品與/r/n對/r/n照/r/n藥/r/n品或安慰/r/n劑/r/n只需在外形上一致。（/r/n×/r/n）/r/n137./r/n每一位受/r/n試/r/n者在/r/n試驗/r/n中的有關(guān)/r/n資/r/n料均/r/n應(yīng)記錄/r/n于/r/n預(yù)/r/n先按/r/n試驗/r/n要求而/r/n設(shè)計/r/n的病例/r/n報/r/n告表中。（/r/n√/r/n）/r/n138./r/n研究者必/r/n須/r/n熟悉本/r/n規(guī)/r/n范并遵守國家有關(guān)法律、法/r/n規(guī)/r/n和道德/r/n規(guī)/r/n范。（/r/n√/r/n）/r/n139./r/n臨床試驗的全過程包括方案設(shè)計、組織、實施、記錄、分析、總結(jié)和報告。/r/n（/r/n√）/r/n140./r/n臨/r/n床/r/n試驗/r/n主要目的是保障受/r/n試/r/n者的/r/n權(quán)/r/n益。（/r/n×/r/n）/r/n141./r/n臨/r/n床/r/n試驗總結(jié)報/r/n告的內(nèi)容/r/n應(yīng)報/r/n告隨機/r/n進(jìn)/r/n入治/r/n療組/r/n的/r/n實際/r/n病例數(shù)，并分析中途剔除的病例及其理由。（/r/n√/r/n）/r/n142./r/n研究者必/r/n須/r/n是在/r/n職/r/n主任，以有/r/n權(quán)/r/n支配/r/n進(jìn)/r/n行/r/n臨/r/n床/r/n試驗/r/n所需的人/r/n員/r/n及/r/n設(shè)備/r/n。（/r/n×/r/n）/r/n143./r/n臨/r/n床/r/n試驗/r/n方案中要寫明/r/n統(tǒng)計/r/n學(xué)/r/n處/r/n理方法，以后任何/r/n變動須/r/n在/r/n臨/r/n床/r/n試驗總結(jié)報/r/n告中述明并/r/n說/r/n明其理由。（/r/n√/r/n）/r/n144./r/n臨/r/n床/r/n試驗/r/n數(shù)據(jù)/r/n統(tǒng)計/r/n分析中，/r/n對/r/n治/r/n療/r/n作用的/r/n評/r/n價/r/n應(yīng)/r/n依據(jù)于/r/n顯/r/n著性/r/n檢驗/r/n。（/r/n×/r/n）/r/n145./r/n臨/r/n床/r/n試驗/r/n只需以道德/r/n倫/r/n理/r/n為標(biāo)/r/n準(zhǔn)。（/r/n×/r/n）/r/n146./r/n知情同意/r/n書應(yīng)選/r/n用受/r/n試/r/n者和其法定代表人能/r/n夠/r/n理解的/r/n語/r/n言和文字。（/r/n√/r/n）/r/n147./r/n倫/r/n理委/r/n員/r/n會中至少有/r/n1/r/n人從事非醫(yī)/r/n藥專業(yè)/r/n。（/r/n√/r/n）/r/n148./r/n監(jiān)查員應(yīng)/r/n遵循/r/n標(biāo)/r/n準(zhǔn)操作/r/n規(guī)/r/n范/r/n進(jìn)/r/n行工作。（/r/n√/r/n）/r/n149./r/n各/r/n檢測項/r/n目必/r/n須/r/n注明國/r/n際統(tǒng)/r/n一/r/n規(guī)/r/n定的正常/r/n值/r/n。（/r/n×/r/n）/r/n150./r/n臨/r/n床/r/n試驗/r/n方案中/r/n應(yīng)/r/n根據(jù)研究者的/r/n經(jīng)驗/r/n制定/r/n試驗藥/r/n與/r/n對/r/n照/r/n藥/r/