2022完整版GCP考试题库及参考答案【综合卷】必考

2022/r/n完整版/r/nGCP/r/n考/r/n试题库/r/n一/r/n./r/n选择题/r/n(/r/n共/r/n25/r/n题/r/n，共/r/n50/r/n分/r/n)/r/n1./r/n在试验中，修改知情同意书时，下列哪项是错误的？/r/nA.书面修改知情同意书

/r/nB.报伦理委员会批准/r/nC.再次征得受试者同意/r/nD.已签署的不必再次签署修改后的知情同意书/r/n2./r/n下列哪一项不是临床试验单位的必备条件？/r/nA.设施条件必须符合安全有效地进行临床试验的需要/r/nB/r/n./r/n后勤条件必须符合安全有效地进行临床试验的需要/r/nC/r/n./r/n三级甲等医院/r/nD/r/n./r/n人员条件必须符合安全有效地进行临床试验的需要/r/n3./r/n关于签署知情同意书，下列哪项不正确？/r/nA.受试者在充分了解全部试验有关情况后同意并签字/r/nB.受试者的合法代表了解全部试验有关情况后同意并签字/r/nC/r/n./r/n见证人在见证整个知情过程后，受试者或其合法代表口头同意，见证人签字/r/nD/r/n./r/n无行为能力的受试者，必须自愿方可参加试验/r/n4./r/n伦理委员会书面签发其意见时，不需附带下列哪一项？/r/nA.出席会议的委员名单/r/nB/r/n./r/n出席会议的委员的专业情况/r/nC/r/n./r/n出席会议委员的研究项目/r/nD/r/n./r/n出席会议委员的签名/r/n5./r/n无行为能力的受试者，其知情同意的过程不包括：/r/nA.伦理委员会原则上同意/r/nB/r/n./r/n研究者认为参加试验符合受试者本身利益/r/nC/r/n./r/n研究者可在说明情况后代替受试者或其法定监护人在知情同意书上签字并注明日期/r/nD/r/n./r/n其法定监护人在知情同意书上签字并注明签字日期/r/n6./r/n伦理委员会的工作应：/r/nA./r/n接受申办者意见/r/n

/r/nB/r/n./r/n接受研究者意见/r/nC/r/n./r/n接受参试者意见/r/nD/r/n./r/n是独立的，不受任何参与试验者的影响/r/n7./r/n下列哪项规定了人体生物医学研究的道德原则？/r/nA.国际医学科学组织委员会颁布的《实验室研究指南》/r/nB/r/n./r/n国际医学科学组织委员会颁布的《人体生物医学研究指南》/r/nC/r/n./r/n国际医学科学组织委员会颁布的《人体生物医学研究国际道德指南》/r/nD/r/n./r/n国际医学科学组织委员会颁布的《实验动物研究指南》/r/n8./r/n伦理委员会审阅试验方案中一般不考虑：/r/nA.受试者入选方法是否适当/r/nB/r/n./r/n知情同意书内容是否完整易懂/r/nC/r/n./r/n受试者是否有相应的文化程度/r/nD/r/n./r/n受试者获取知情同意书的方式是否适当/r/n9./r/n无行为能力的受试者，其知情同意书必须由谁签署？/r/nA.研究者

B.见证人/r/nC.监护人

/r/nD.以上三者之一，视情况而定/r/n10./r/n下列哪/r/n项/r/n不是申/r/n办/r/n者的/r/n职责/r/n？/r/nA./r/n任命/r/n监查员/r/n，/r/n监查临/r/n床/r/n试验/r/nB./r/n建立/r/n临/r/n床/r/n试验/r/n的/r/n质/r/n量控制与/r/n质/r/n量保/r/n证/r/n系/r/n统/r/nC./r/n对试验/r/n用/r/n药/r/n品作出医/r/n疗/r/n决定/r/nD./r/n保/r/n证试验/r/n用/r/n药/r/n品/r/n质/r/n量合格/r/n11./r/n由医学/r/n专业/r/n人/r/n员/r/n、法律/r/n专/r/n家及非医/r/n务/r/n人/r/n员组/r/n成的独立/r/n组织/r/n，其/r/n职责为/r/n核/r/n查临/r/n床/r/n试验/r/n方案及附件是否合乎道德并/r/n为/r/n之提供公众保/r/n证/r/n，确保受/r/n试/r/n者的安全、健康和/r/n权/r/n益受到保/r/n护/r/n。/r/nA./r/n临/r/n床/r/n试验/r/n

B./r/n知情同意/r/nC./r/n伦/r/n理委/r/n员/r/n会/r/n

D./r/n不良事件/r/n12./r/n发/r/n起一/r/n项临/r/n床/r/n试验/r/n，并/r/n对该试验/r/n的启/r/n动/r/n、管理、/r/n财务/r/n和/r/n监查负责/r/n的公司、机构和/r/n组织/r/n。/r/nA./r/n协调/r/n研究者/r/n

B./r/n监查员/r/nC./r/n研究者/r/n

/r/nD./r/n申/r/n办/r/n者/r/n13./r/n凡新/r/n药临/r/n床/r/n试验/r/n及人体生物学研究下列哪/r/n项/r/n不正确？/r/n

/r/nA./r/n向/r/n卫/r/n生行政部/r/n门递/r/n交申/r/n请/r/n即可/r/n实/r/n施/r/nB/r/n需向/r/n药/r/n政管理部/r/n门递/r/n交申/r/n请/r/nC/r/n需/r/n经伦/r/n理委/r/n员/r/n会批准后/r/n实/r/n施/r/nD/r/n需/r/n报药/r/n政管理部/r/n门/r/n批准后/r/n实/r/n施/r/n14./r/n伦理委员会的工作指导原则包括：/r/nA.中国有关法律

/r/nB/r/n./r/n药品管理法/r/nC/r/n./r/n赫尔辛基宣言/r/n

/r/nD/r/n./r/n以上三项/r/n15./r/n试验/r/n完成后的一份/r/n详/r/n尽/r/n总结/r/n，包括/r/n试验/r/n方法和材料、/r/n结/r/n果描述与/r/n评/r/n估、/r/n统计/r/n分析以及最/r/n终/r/n所/r/n获鉴/r/n定性的、合乎道德的/r/n统计/r/n学和/r/n临/r/n床/r/n评/r/n价/r/n报/r/n告。/r/nA./r/n病例/r/n报/r/n告表/r/n

/r/nB./r/n总结报/r/n告/r/nC./r/n试验/r/n方案/r/n

D./r/n研究者手册/r/n16./r/n伦理委员会会议的记录应保存至：/r/nA.临床试验结束后五年/r/nB药品上市后五年/r/nC/r/n./r/n临床试验开始后五年/r/nD/r/n./r/n临床试验批准后五年/r/n17./r/n试验开始前，申办者和研究者的职责分工协议不应包括：/r/nA.试验方案

B/r/n./r/n试验监查/r/nC/r/n./r/n药品生产/r/n

/r/nD/r/n./r/n试验稽查/r/n18./r/n申/r/n办/r/n者提供的研究者手册不包括：/r/nA./r/n试验/r/n用/r/n药/r/n的化学/r/n资/r/n料和数据/r/nB./r/n试验/r/n用/r/n药/r/n的化学、/r/n药/r/n学/r/n资/r/n料和数据/r/nC./r/n试验/r/n用/r/n药/r/n的化学、毒理学/r/n资/r/n料和数据/r/nD./r/n试验/r/n用/r/n药/r/n的生/r/n产/r/n工/r/n艺资/r/n料和数据/r/n19./r/n试验方案中不包括下列哪项？/r/nA.进行试验的场所/r/nB研究者的姓名、地址、资格/r/nC受试者的姓名、地址/r/nD申办者的姓名、地址/r/n20./r/n用以保/r/n证/r/n与/r/n临/r/n床/r/n试验/r/n相关活/r/n动/r/n的/r/n质/r/n量达到要求的操作性技/r/n术/r/n和/r/n规/r/n程。/r/nA./r/n稽/r/n查/r/n

B./r/n监查/r/nC./r/n视/r/n察/r/n

/r/nD./r/n质/r/n量控制/r/n21./r/n伦理委员会应成立在：/r/nA.申办者单位

/r/nB/r/n./r/n临床试验单位/r/nC/r/n./r/n药政管理部门/r/n

/r/nD/r/n./r/n监督检查部门/r/n22./r/n下面哪一个不是《/r/n药/r/n品/r/n临/r/n床/r/n试验/r/n管理/r/n规/r/n范》适用的范畴？/r/nA./r/n新/r/n药/r/n各期/r/n临/r/n床/r/n试验/r/n

/r/nB/r/n新/r/n药临/r/n床/r/n试验/r/n前研究/r/nC/r/n人体生物等效性研究/r/n

/r/nD/r/n人体生物利用度研究/r/n23./r/n下列哪/r/n项/r/n是研究者的/r/n职责/r/n？/r/nA./r/n任命/r/n监查员/r/n，/r/n监查临/r/n床/r/n试验/r/nB./r/n建立/r/n临/r/n床/r/n试验/r/n的/r/n质/r/n量控制与/r/n质/r/n量保/r/n证/r/n系/r/n统/r/nC./r/n对试验/r/n用/r/n药/r/n品作出医/r/n疗/r/n决定/r/nD./r/n保/r/n证试验/r/n用/r/n药/r/n品/r/n质/r/n量合格/r/n24./r/n下列哪些不是临床试验前的准备和必要条件？/r/nA.必须有充分的理由/r/nB/r/n./r/n必须所有的病例报告表真实、准确/r/nC/r/n./r/n申办者准备和提供临床试验用药品/r/nD/r/n./r/n研究者充分了解中国有关药品管理法/r/n25./r/n下列哪一项是临床试验前准备的必要条件？/r/nA.必须有充分理由/r/nB/r/n./r/n研究单位和研究者需具备一定条件/r/nC/r/n./r/n所有受试者均已签署知情同意书/r/nD/r/n./r/n以上三项必须同时具备/r/n二/r/n./r/n判断/r/n题/r/n(/r/n共/r/n50/r/n题/r/n，共/r/n100/r/n分/r/n)/r/n1./r/n临/r/n床/r/n试验/r/n中随机分配受/r/n试/r/n者只需/r/n严/r/n格按/r/n试验/r/n方案的/r/n设计/r/n步/r/n骤执/r/n行，不必另外/r/n记录/r/n。（/r/n×/r/n）/r/n2./r/n伦/r/n理委/r/n员/r/n会在/r/n签发书/r/n面意/r/n见时/r/n只需写明同意、作必要修改后同意、不同意、/r/n终/r/n止或/r/n暂/r/n停先前已批准/r/n试验/r/n的意/r/n见/r/n，不需其他附件。（/r/n×/r/n）/r/n3./r/n申/r/n办/r/n者/r/n应/r/n及/r/n时/r/n向/r/n伦/r/n理委/r/n员/r/n会提交/r/n临/r/n床/r/n试验/r/n方案，/r/n请/r/n求批准。（/r/n×/r/n）/r/n4./r/n每一位受/r/n试/r/n者在/r/n试验/r/n中的有关/r/n资/r/n料均/r/n应记录/r/n于/r/n预/r/n先按/r/n试验/r/n要求而/r/n设计/r/n的病例/r/n报/r/n告表中。（/r/n√/r/n）/r/n5./r/n为/r/n保/r/n证质/r/n量，申/r/n办/r/n者不可委托其他/r/n组织执/r/n行/r/n临/r/n床/r/n试验/r/n中的某些工作和任/r/n务/r/n。（/r/n×/r/n）/r/n6./r/n临/r/n床/r/n试验/r/n所在/r/n单/r/n位的/r/n设/r/n施条件/r/n应/r/n符合/r/n临/r/n床/r/n试验/r/n工作的要求。（/r/n√/r/n）/r/n7./r/n伦/r/n理委/r/n员/r/n会/r/n审阅试验/r/n方案/r/n时/r/n，不包括/r/n对/r/n申/r/n办/r/n者/r/n资/r/n格的稽/r/n查/r/n。（/r/n√/r/n）/r/n8./r/n在/r/n临/r/n床/r/n试验过/r/n程中/r/n发/r/n生的不良事件若可能与/r/n试验药/r/n品无关，/r/n则/r/n研究者可不做/r/n记录/r/n和/r/n报/r/n告。（/r/n×/r/n）/r/n9./r/n每一个/r/n临/r/n床/r/n试验应/r/n有/r/n5/r/n位以上/r/n监查员/r/n。（/r/n×/r/n）/r/n10./r/n研究者和申/r/n办/r/n者按本/r/n规/r/n范/r/n规/r/n定的/r/n职责/r/n分工，不需另外/r/n协议/r/n分工。（/r/n×/r/n）/r/n11./r/n临/r/n床/r/n观/r/n察及/r/n实验/r/n室/r/n检查/r/n的/r/n项/r/n目和/r/n测/r/n定次数、随/r/n访/r/n步/r/n骤/r/n可根据/r/n试验/r/n情况而定，在/r/n临/r/n床/r/n试验/r/n方案中可不包括/r/n该项/r/n内容。（/r/n×/r/n）/r/n12./r/n临/r/n床/r/n试验/r/n方案/r/n应/r/n包括/r/n临/r/n床/r/n试验/r/n的/r/n题/r/n目和立/r/n题/r/n的理由。（/r/n√/r/n）/r/n13./r/n研究者必/r/n须/r/n保/r/n证/r/n所有/r/n试验药/r/n品/r/n仅/r/n用于/r/n该临/r/n床/r/n试验/r/n的受/r/n试/r/n者，其/r/n剂/r/n量与用法/r/n应/r/n遵照/r/n试验/r/n方案，剩余的/r/n试验药/r/n品自行焚/r/n毁/r/n，整个/r/n过/r/n程需由/r/n专/r/n人/r/n负责/r/n并/r/n记录/r/n在案。（/r/n×/r/n）/r/n14./r/n在/r/n设/r/n盲的/r/n试验/r/n中，如遇/r/n紧/r/n急情况，允/r/n许对/r/n个/r/n别/r/n受/r/n试/r/n者破盲而了解其所接受的治/r/n疗/r/n，但必/r/n须/r/n在病例/r/n报/r/n告上述明理由。（/r/n√/r/n）/r/n15./r/n研究者必/r/n须/r/n是在/r/n职/r/n主任，以有/r/n权/r/n支配/r/n进/r/n行/r/n临/r/n床/r/n试验/r/n所需的人/r/n员/r/n及/r/n设备/r/n。（/r/n×/r/n）/r/n16./r/n病例/r/n报/r/n告表是/r/n临/r/n床/r/n试验报/r/n告的/r/n记录/r/n方式。（/r/n×/r/n）/r/n17./r/n在/r/n临/r/n床/r/n试验总结报/r/n告中，将/r/n严/r/n重不良事件的/r/n发/r/n生例数和/r/n发/r/n生率/r/n单/r/n独列表，但不需/r/n评/r/n价和/r/n讨论/r/n。（/r/n×/r/n）/r/n18./r/n临/r/n床/r/n试验统计报/r/n告必/r/n须/r/n与/r/n临/r/n床/r/n试验总结报/r/n告相符。（/r/n√/r/n）/r/n19./r/n伦/r/n理委/r/n员/r/n会工作的指/r/n导/r/n原/r/n则/r/n之一是《赫/r/n尔/r/n辛基宣言》。（/r/n√/r/n）/r/n20./r/n研究者如有适当理由可不接受/r/n监查员/r/n的定期/r/n访问/r/n和主管部/r/n门/r/n的稽/r/n查/r/n和/r/n视/r/n察。（/r/n×/r/n）/r/n21./r/n临/r/n床/r/n试验设计/r/n与/r/n结/r/n果表达及分析的各步/r/n骤/r/n中，均需有熟悉生物/r/n统计/r/n学的人/r/n员/r/n参加。（/r/n√/r/n）/r/n22./r/n伦/r/n理委/r/n员/r/n会不需要/r/n对试验设计/r/n的科学效率/r/n进/r/n行/r/n审阅/r/n。（/r/n×/r/n）/r/n23./r/n伦/r/n理委/r/n员/r/n会/r/n应/r/n在/r/n药/r/n政管理部/r/n门/r/n建立。（/r/n×/r/n）/r/n24./r/n临/r/n床/r/n试验/r/n方案中/r/n试验设计/r/n包括/r/n对/r/n照或开放、平行或交叉、双盲或/r/n单/r/n盲、随机化方法与步/r/n骤/r/n、/r/n单/r/n中心与多中心。（/r/n√/r/n）/r/n25./r/n病例/r/n报/r/n告表是/r/n临/r/n床/r/n试验/r/n中/r/n临/r/n床/r/n资/r/n料的/r/n记录/r/n方式。（/r/n√/r/n）/r/n26./r/n试验/r/n用/r/n药/r/n品若属同一生/r/n产/r/n批号，/r/n则/r/n不需/r/n编码/r/n和/r/n贴/r/n有特殊/r/n标签/r/n。（/r/n×/r/n）/r/n27./r/n监查员应/r/n遵循/r/n临/r/n床/r/n试验/r/n方案/r/n进/r/n行工作。（/r/n√/r/n）/r/n28./r/n受/r/n试/r/n者在/r/n进/r/n入/r/n临/r/n床/r/n试验/r/n之前，必/r/n须签/r/n署知情同意/r/n书/r/n。（/r/n√/r/n）/r/n29./r/n在/r/n设/r/n盲的/r/n试验/r/n中，如遇/r/n紧/r/n急情况，/r/n应/r/n立即通知申/r/n办/r/n者，申/r/n办/r/n者在/r/n场时/r/n允/r/n许对/r/n个/r/n别/r/n受/r/n试/r/n者破盲而了解其所接受的治/r/n疗/r/n，但必/r/n须/r/n在病例/r/n报/r/n告上述明理由。（/r/n×/r/n）/r/n30./r/n至少部分/r/n临/r/n床/r/n试验/r/n的研究者必/r/n须经过/r/n本/r/n规则/r/n培/r/n训/r/n。（/r/n×/r/n）/r/n31./r/n研究者提前/r/n终/r/n止或/r/n暂/r/n停一/r/n项临/r/n床/r/n试验/r/n必/r/n须/r/n通知受/r/n试/r/n者、/r/n药/r/n政管理部/r/n门/r/n、申/r/n办/r/n者和/r/n伦/r/n理委/r/n员/r/n会，并述明理由。（/r/n√/r/n）/r/n32./r/n研究者/r/n负责/r/n做出与/r/n临/r/n床/r/n试验/r/n相关的医/r/n疗/r/n决定，保/r/n证/r/n受/r/n试/r/n者在/r/n试验/r/n期/r/n间/r/n出/r/n现/r/n不良事件/r/n时/r/n得到适当的治/r/n疗/r/n。（/r/n√/r/n）/r/n33./r/n药/r/n政管理部/r/n门/r/n可委托稽/r/n查/r/n人/r/n员对临/r/n床/r/n试验进/r/n行系/r/n统/r/n性/r/n检查/r/n。（/r/n√/r/n）/r/n34./r/n研究者必/r/n须/r/n保/r/n证/r/n所有/r/n试验药/r/n品/r/n仅/r/n用于/r/n该临/r/n床/r/n试验/r/n的受/r/n试/r/n者，其/r/n剂/r/n量与用法/r/n应/r/n遵照/r/n试验/r/n方案，剩余的/r/n试验药/r/n品退回申/r/n办/r/n者，整个/r/n过/r/n程需由/r/n专/r/n人/r/n负责/r/n并/r/n记录/r/n在案。（/r/n√/r/n）/r/n35./r/n已知/r/n对/r/n人体的可能危/r/n险/r/n性和受益/r/n应/r/n在知情同意/r/n书/r/n中/r/n详细/r/n写明，/r/n临/r/n床/r/n试验/r/n方案不包括/r/n这/r/n一/r/n项/r/n内容。（/r/n×/r/n）/r/n36./r/n临/r/n床/r/n试验/r/n方案中/r/n应/r/n根据/r/n药/r/n效与/r/n药/r/n代/r/n动/r/n力学研究/r/n结/r/n果及量效关系制定/r/n试验药/r/n与/r/n对/r/n照/r/n药/r/n的/r/n给药/r/n途径、/r/n剂/r/n量、/r/n给药/r/n次数和有关合并用/r/n药/r/n的/r/n规/r/n定。（/r/n√/r/n）/r/n37./r/n伦/r/n理委/r/n员/r/n会的工作/r/n记录/r/n要保持到/r/n试验结/r/n束后/r/n2/r/n年。（/r/n×/r/n）/r/n38./r/n申/r/n办/r/n者/r/n应/r/n保存/r/n临/r/n床/r/n试验资/r/n料，保存期/r/n为临/r/n床/r/n试验结/r/n束后至少/r/n2/r/n年。（/r/n×/r/n）/r/n39./r/n伦/r/n理委/r/n员/r/n会/r/n签发赞/r/n同或不/r/n赞/r/n同意/r/n见/r/n的批件/r/n应/r/n保存。其他的会/r/n议/r/n及决定不必做/r/n书/r/n面/r/n记录/r/n和保存。（/r/n×/r/n）/r/n40./r/n多中心临床试验应建立管理办法以使各试验中心的研究者遵从试验方案，包括在违背方案时中止其继续参加试验的措施。/r/n（/r/n√）/r/n41./r/n发/r/n生/r/n严/r/n重不良事件后，要采取必要措施以保/r/n证/r/n受/r/n试/r/n者安全并及/r/n时报/r/n告/r/n药/r/n政管理部/r/n门/r/n，也向涉及相同/r/n药/r/n品的/r/n临/r/n床/r/n试验/r/n的其他研究者通/r/n报/r/n。（/r/n√/r/n）/r/n42./r/n在双盲/r/n临/r/n床/r/n试验/r/n中，研究中的/r/n药/r/n品与/r/n对/r/n照/r/n药/r/n品或安慰/r/n剂/r/n只需在外形上一致。（/r/n×/r/n）/r/n43./r/n多中心/r/n临/r/n床/r/n试验实/r/n施/r/n计/r/n划中/r/n应/r/n考/r/n虑/r/n在/r/n试验/r/n中期/r/n组织/r/n召开研究会/r/n议/r/n。（/r/n√/r/n）/r/n44./r/n任何/r/n临/r/n床/r/n试验/r/n要以受/r/n试/r/n者/r/n绝/r/n不受到/r/n伤/r/n害/r/n为/r/n必要条件。（/r/n×/r/n）/r/n45./r/n各种/r/n实验/r/n室数据均/r/n应记录/r/n或将原始/r/n报/r/n告粘/r/n贴/r/n在病例/r/n报/r/n告表上，在正常范/r/n围/r/n的数据也/r/n应记录/r/n。（/r/n√/r/n）/r/n46./r/n申/r/n办/r/n者可委托合同研究/r/n组织执/r/n行/r/n临/r/n床/r/n试验/r/n中的某些工作和任/r/n务/r/n。（/r/n√/r/n）/r/n47./r/n监查员/r/n由申/r/n办/r/n者任命，并/r/n为/r/n研究者所接受。（/r/n√/r/n）/r/n48./r/n监查员/r/n需在/r/n试验/r/n前确/r/n认试验/r/n所在/r/n单/r/n位是否已具/r/n备试验/r/n所需的/r/n实验/r/n室/r/n设备/r/n。（/r/n√/r/n）/r/n49./r/n证实/r/n受/r/n试/r/n者的/r/n权/r/n益受到保