[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fJsc6h62Yu_l2fV88t91FTSc7to7a-C5YJAVtlw2ZGjw":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",304545678,[8,9,10,11,12],"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",{"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","关于CRA的职责,下述说法正确的是( )",[22,33,42,51,60,69,72,81,90,100],{"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":41,"source":31,"type":32},[],304545674,[37,38,39,40],"适应证","试验用药品","试验目的","试验设计","试验方案名称包含的信息有( )",{"answer":43,"createTime":5,"id":44,"options":45,"question":50,"source":31,"type":32},[],304545675,[46,47,48,49],"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":52,"createTime":5,"id":53,"options":54,"question":59,"source":31,"type":32},[],304545676,[55,56,57,58],"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":61,"createTime":5,"id":62,"options":63,"question":68,"source":31,"type":32},[],304545677,[64,65,66,67],"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":70,"createTime":5,"id":6,"options":71,"question":20,"source":31,"type":32},[],[8,9,10,11,12],{"answer":73,"createTime":5,"id":74,"options":75,"question":80,"source":31,"type":32},[],304545679,[76,77,78,79],"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":82,"createTime":5,"id":83,"options":84,"question":89,"source":31,"type":32},[],304545680,[39,85,86,87,88],"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","下列属于知情同意书必需的内容的是( )",{"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( )"]