[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fhS5p5jYA_RmY9ds9b2clDbJb5CecyLC3Hbf9vVg9PEw":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":13,"question":20,"related":21,"source":31,"type":32},[],"2026-01-06 14:11:36",304545680,[8,9,10,11,12],"试验目的","研究资料的归档要求","参加该试验的预计受试者人数","研究者的专业资格和经验","试验预期的受益和可能发生的风险",{"count":14,"courseId":15,"courseImg":16,"courseName":17,"workId":18,"workName":19},70,"53e1d2ef4961cca8eea3e23969ad2cb9","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002F03a579384a6dc297c89809b582fcc767.png","默认课程","exam_168773854","GCP检测","下列属于知情同意书必需的内容的是( )",[22,33,41,50,59,68,78,87,90,100],{"answer":23,"createTime":5,"id":24,"options":25,"question":30,"source":31,"type":32},[],304545673,[26,27,28,29],"确保项目正常进行","保障受试者安全","确保治疗效果","合理控制成本","规范化管理试验用药品的意义","v1",1,{"answer":34,"createTime":5,"id":35,"options":36,"question":40,"source":31,"type":32},[],304545674,[37,38,8,39],"适应证","试验用药品","试验设计","试验方案名称包含的信息有( )",{"answer":42,"createTime":5,"id":43,"options":44,"question":49,"source":31,"type":32},[],304545675,[45,46,47,48],"GSP-----药品经营质量管理规范","GMP----药品生产质量管理规范","GCP---药物临床试验质量管理规范","GVP-----药物警戒质量管理规范","下列缩写与中文名称对应正确的有( )",{"answer":51,"createTime":5,"id":52,"options":53,"question":58,"source":31,"type":32},[],304545676,[54,55,56,57],"充分理解","书面签署","完全告知","自主选择","知情同意的准则有( )",{"answer":60,"createTime":5,"id":61,"options":62,"question":67,"source":31,"type":32},[],304545677,[63,64,65,66],"填写病例报告表","处理剩余的试验用药品","做出相关的医疗决定","报告不良事件","下列属于研究者的职责的是( )",{"answer":69,"createTime":5,"id":70,"options":71,"question":77,"source":31,"type":32},[],304545678,[72,73,74,75,76],"参与病例报告表的填写","以谈话形式对受试者进行知情同意","保证临床试验按照试验方案、标准操作规程和相关法律法规要求实施、记录和报告","预约接待受试者","每次监查后,应当及时书面报告申办者","关于CRA的职责,下述说法正确的是( )",{"answer":79,"createTime":5,"id":80,"options":81,"question":86,"source":31,"type":32},[],304545679,[82,83,84,85],"研究者发起的临床研究","医疗器械临床试验","药物临床试验","新医疗新技术研究项目","以下需要伦理审查的项目有( )",{"answer":88,"createTime":5,"id":6,"options":89,"question":20,"source":31,"type":32},[],[8,9,10,11,12],{"answer":91,"createTime":5,"id":92,"options":93,"question":99,"source":31,"type":32},[],304545681,[94,95,96,97,98],"项目研讨会","项目设计","项目立项","项目结束","项目运行","药物临床试验开展的流程包括( )",{"answer":101,"createTime":5,"id":102,"options":103,"question":108,"source":31,"type":32},[],304545682,[104,105,106,107],"如果父母同意参加临床试验并签署,该学生不签署即可参加","如果该学生不愿意参加,父母也需要尊重其意见","需要学生和父母同时进行签署","已有阅读签署能力自行签署即可","11岁学生参加临床试验签署知情同意书时注意( )"]