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["附件4"]
["兽药临床试验质量管理规范监督检查标准（兽用生物制品）"]
["使用说明：\n1．本标准根据《兽药临床试验质量管理规范》（以下简称兽药GCP）制定。\n2．本标准共涉及条款190条，A表、B表2部分。A表（监督检查综合标准）涉及条款58条，关键条款（条款号前加“*”）15条，一般条款43条；B表（试验项目监督检查标准）涉及条款132条，关键条款33条，一般条款99条。\n3．在实施兽药GCP监督检查时，须确定相应的检查范围和内容，按照试验项目进行打分。例如：报告3个试验项目，需使用A表1份，B表3份，分别对3个具体试验项目进行评定。                  \n4. 评定方式：评定结果分为“N”、“Yˉ”和“Y”3档。凡某条款得分在75分以上的，判定为符合要求，评定结果标为“Y”； 凡某条款得分在50-75分之间的，判定为基本符合要求，评定结果标为“Yˉ”；凡某条款得分在50分以下的，判定为不符合要求，评定结果标为“N”。对于不涉及的条款，标为“-”。                                                                                                                                                                                                                            5.结果统计：一般条款中，1个“N”折合成3个“Yˉ”，关键条款的“N”不折合为“Yˉ”，结果按下表统计。                                                                6.A表评定意见为不符合要求的，不再对具体试验项目进行评定。\n"]
["7．结果评定"]
["A表基本表"]
["关键条款的缺陷项目数量","一般条款的缺陷项目数量","评定意见"]
[]
["N＜1 且 Yˉ≤2","Yˉ≤6","基本符合要求,可对试验项目进行评定。"]
["N≥1",null,"不符合要求，不再对具体试验项目进行评定。"]
["N＜1 且 Yˉ＞2"]
[null,"Yˉ＞6"]
["B表项目评定标准表"]
["关键条款的缺陷项目数量","一般条款的缺陷项目数量","评定意见"]
[]
["N＜1 且 Yˉ≤2"," Yˉ≤15","该试验项目基本符合兽药GCP要求。"]
["N≥1",null,"该试验项目不符合兽药GCP要求。"]
["N＜1 且 Yˉ＞2"]
[null,"Yˉ＞15"]

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[" A表--监督检查综合标准"]
["序号","章节","条款编号","条款内容"]
[1,"A01 组织机构","A0101*","应具有独立的法人资格或有法人代表授权"]
[2,null,"A0102","应设置合理的组织机构,各部门职能明确、运行有序"]
[3,null,"A0103","应配备与临床试验相适应的管理人员和技术人员"]
[4,null,"A0104","动物管理委员会/伦理委员会"]
[5,"A02 单位负责人","A0201*","兽医、生物、药学等相关专业本科以上学历"]
[6,null,"A0202*","兽医、生物、药学等相关专业高级职称"]
[7,null,"A0203","经过临床试验技术和兽药GCP培训"]
[8,null,"A0204","组织过兽药临床试验"]
[9,null,"A0205","参加过兽药临床试验"]
[10,null,"A0206*","机构负责人变更的，应提供农业部相关机构提供的资格确认有关资料"]
[11,null,"A0207*","熟悉申请人所提供的与临床试验有关的资料与文献"]
[12,"A03 兽药临床试验机构办公室负责人及设施","A0301","设立兽药临床试验机构办公室并指定负责人"]
[13,null,"A0302","具有兽医、生物、药学等相关专业基本知识"]
[14,null,"A0303","具有参加或组织过兽药临床试验的专业经历"]
[15,null,"A0304","经过临床试验技术和GCP培训"]
[16,null,"A0305","能够按照兽药临床试验管理运行模式进行工作"]
[17,null,"A0306","掌握GCP内容和相关法律法规及兽药临床试验管理技术"]
[18,null,"A0307","能协调和解决药物临床试验过程中出现的问题"]
[19,null,"A0308","专用办公室、符合档案管理要求的专用资料档案室、文件柜（带锁）、传真机等办公设备"]
[20,null,"A0309*","样品接收、设盲和揭盲室"]
[21,"A04 兽药临床试验管理制度","A0401","兽药临床试验运行管理制度（包括机构办公室工作制度、项目审批制度和临床试验资料归档管理制度等）"]
[22,null,"A0402*","项目的试验用兽药（包括受试兽药和对照兽药）及试验用品的管理制度"]
[23,null,"A0403","设备管理制度"]
[24,null,"A0404","菌毒种管理制度"]
[25,null,"A0405*","生物安全防范制度"]
[26,null,"A0406","剧毒品、危险化学品、易制毒化学品安全管理制度"]
[27,null,"A0407*","临床试验动物及废弃物处理制度"]
[28,null,"A0408","动物福利和伦理相关管理制度"]
[29,null,"A0409*","质量控制与质量管理制度"]
[30,"A04 兽药临床试验管理制度","A0410","设施与环境控制制度"]
[31,null,"A0411*","试验记录与报告管理制度"]
[32,null,"A0412","试验动物的饲养与管理制度"]
[33,null,"A0413","试验动物房管理制度"]
[34,null,"A0414*","人员培训制度"]
[35,null,"A0415","文件管理制度"]
[36,null,"A0416","合同管理制度"]
[37,null,"A0417","财务等其他相关的管理制度"]
[38,null,"A0418*","防范和处理兽药临床试验中突发事件的应急预案"]
[39,"A05 试验设计技术要求","A0501","临床试验方案内容应符合有关试验指导原则规定，并经相关负责人批准"]
[40,null,"A0502","试验动物主人知情同意书应由试验项目负责人与试验动物主人或法定代理人签署"]
[41,null,"A0503","应有经试验项目负责人和申请人签字的临床试验方案"]
[42,null,"A0504","应有经多方签署的多中心临床试验协议"]
[43,null,"A0505","病例记录或试验记录设计规范"]
[44,null,"A0506*","病例报告表全部记录的内容可追溯"]
[45,null,"A0507","兽药临床试验总结报告规范"]
[46,null,"A0508","其他相关试验设计技术要求规范"]
[47,"A06 标准操作规程(SOP) ","A0601","盲底保存SOP "]
[48,null,"A0602","原始资料记录SOP"]
[49,null,"A0603","试验数据记录SOP "]
[50,null,"A0604","病例报告表记录SOP "]
[51,null,"A0605","兽药临床试验数据管理SOP"]
[52,null,"A0606","不良事件及严重不良事件处理SOP "]
[53,null,"A0607","严重不良事件报告SOP "]
[54,null,"A0608","实验室检测及质量控制SOP "]
[55,null,"A0609","对各兽药临床试验项目的质量控制SOP "]
[56,null,"A0610","试验资料和文件归档管理SOP "]
[57,null,"A0611","应具有其他相关SOP"]
[58,"A07已完成兽药临床试验情况","A0701*","完成此次申报兽药临床试验项目1次以上（近5年）"]

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["B表--试验项目监督检查标准"]
["序号","章节","条款编号","条款内容"]
[1,"B01*试验项目负责人","B0101*","兽医、药学等专业本科以上学历"]
[2,null,"B0102*","兽医、药学等专业高级职称或10年以上相关工作经验"]
[3,null,"B0103*","经过临床试验技术培训和GCP培训(培训证书)"]
[4,null,"B0104*","组织过兽药临床试验"]
[5,null,"B0105*","参加过兽药临床试验"]
[6,null,"B0106","应有权支配参与该项试验的人员和使用该项试验所需的设施设备"]
[7,null,"B0107*","试验项目负责人变更的，应提供农业部相关机构提供的资格确认有关资料"]
[8,"B02*兽药临床试验方案","B0201*","兽药临床试验方案由试验项目负责人和申请人签字及公章"]
[9,null,"B0202*","兽药临床试验方案内容符合GCP（题目、目的、统计要求、质控等）"]
[10,"B03 试验用兽药的管理","B0301*","试验用兽药（包括受试兽药和对照兽药）的生产应符合兽药GMP，并有质量合格报告"]
[11,null,"B0302","试验用兽药（包括受试兽药和对照兽药）不得转交他人使用或销售"]
[12,null,"B0303*","试验用兽药（包括受试兽药和对照兽药）的各种记录完整（含设盲、揭盲等记录）"]
[13,null,"B0304*","试验用兽药（包括受试兽药和对照兽药）的剂量和用法与试验方案一致"]
[14,null,"B0305","剩余的试验用兽药（包括受试兽药和对照兽药）退回申请人"]
[15,null,"B0306*","专人管理试验用兽药（包括受试兽药和对照兽药）"]
[16,null,"B0307","剩余临床试验兽药的处理记录"]
[17,null,"B0308","试验用兽药（包括受试兽药和对照兽药）仅用于该临床试验的试验动物"]
[18,"B04数据统计与统计分析","B0401*","数据管理的各种步骤记录在案"]
[19,null,"B0402","具有适当的程序保证数据库的保密性"]
[20,null,"B0403*","试验动物分配与试验设计确定的方案一致"]
[21,null,"B0404","紧急情况破盲述明理由"]
[null,"实验室部分"]
[22,"B05 实验室技术人员","B0501","应具有2名以上兽医、生物等相关专业专科以上学历技术人员"]
[23,null,"B0502","应经过临床试验技术和GCP培训"]
[24,null,"B0503","应参加过临床相关试验"]
[25,null,"B0504","主要测试人员应具有完整实施生物样品测试经历和实施样品分析的能力"]
[26,null,"B0505","应具有熟练操作样本检测仪器的能力"]
[27,null,"B0506","应具有熟练操作数据处理、分析软件的能力"]
[28,"B06 现场测试","B0601","GCP知识测试（随机抽查）应符合要求"]
[29,null,"B0602","SOP相关内容操作测试（随机抽查）应符合要求"]
[30,"B07 实验室条件及设施","B0701*","实验室须通过计量认证或实验室认可，且证书在有效期内，满足相对独立、功能明确，符合检测和分析流程的要求"]
[31,null,"B0702*","实验室计量仪器设备已通过计量检定，并在有效期内"]
[32,null,"B0703","应具有样本分离、储存以及运输的基本设备"]
[33,null,"B0704","应具有检测样品的专用超净工作台、生物安全柜"]
[34,null,"B0705","应具有试验用兽药、菌毒种及试验用品专用储藏设施或设备"]
[35,"B08 实验室配备常规仪器设备","B0801","应具有能满足试验项目要求的检验、检测仪器设备"]
[36,null,"B0802","规格齐全的微量加样器"]
[37,null,"B0803","分析仪专用计算机及数据分析处理软件"]
[38,null,"B0804","仪器和实验设备应处于可使用的正常状态"]
[39,null,"B0805","仪器和实验设备使用和维修记录应完整"]
[40,"B09 临床试验实验室管理制度\n\n","B0901","应建立临床试验实验室人员管理制度"]
[41,null,"B0902","试验用兽药（包括标准对照品）管理制度"]
[42,null,"B0903","应建立专用仪器设备管理制度"]
[43,null,"B0906","应建立临床试验实验室质量保证体系"]
[44,null,"B0907","应建立临床试验结果分析质量控制体系"]
[45,null,"B0908","应建立临床试验实验室工作流程"]
[46,"B10 临床试验实验室标准操作规程(SOP)\n\n","B1001","应具有各项检查参数检验SOP "]
[47,null,"B1002","应具有试验数据审核SOP "]
[48,null,"B1003","应具有计量仪器校正SOP "]
[49,null,"B1004","应具有实验室仪器操作SOP "]
[50,null,"B1005","应具有试验数据采集、处理和统计分析SOP "]
[51,null,"B1006","应具有试验质量控制SOP（包括实验动物的剔除，结果筛选）"]
[52,null,"B1007","应具有电子文档保存SOP "]
[53,null,"B1008","应具有样本接收、保存和安全处置SOP "]
[54,null,"B1009","应具有临床试验实验室其它相关SOP "]
[55,"B11 质量保证措施","B1101","应建立临床试验实验室质量保证体系"]
[56,null,"B1102","应建立临床试验结果分析质控体系"]
[57,null,"B1103","临床试验过程应遵循兽药临床试验方案"]
[58,null,"B1104","临床试验过程应执行各种标准操作规程"]
[59,null,"B1105","接受监查员的监查并记录在案"]
[60,"B12 试验记录","B1201","试验记录应及时、准确、规范、完整、真实"]
[61,null,"B1202","原始资料应保存完整"]
[62,null,"B1203","病例报告表应保存完整"]
[63,"B12 试验记录","B1204","病例报告表中的数据应与原始资料一致"]
[64,null,"B1205","病例报告表应附有实验室原始数据报告记录复印件"]
[65,null,"B1206","兽药临床试验资料应保存至临床试验终止后7年"]
[66,null,"B1207","试验总结报告应与兽药临床试验方案要求一致"]
[67,null,"B1208","试验总结报告内容应符合GCP规定"]
[68,null,"B1209","监查记录应保存完整"]
["动物试验部分"]
[69,"B13 动物试验技术人员","B1301","应具有3人以上承担试验项目相关专业中级或以上职称动物试验技术人员"]
[70,null,"B1302","应持有《动物实验从业人员岗位证书》"]
[71,null,"B1303","应经过临床试验技术、GCP培训和生物安全相关知识的培训"]
[72,null,"B1304","具有完整参与临床试验经历的人员"]
[73,null,"B1305","能熟练的操作各项设备设施"]
[74,"B14 现场测试","B1401","GCP知识测试（随机抽查）应符合规定"]
[75,null,"B1402","SOP相关内容测试（随机抽查）应符合规定"]
[76,"B15 兽药临床试验管理制度及SOP","B1501","应建立兽药临床试验工作人员管理制度"]
[77,null,"B1502*","应建立兽药临床试验用兽药管理制度"]
[78,null,"B1503","应建立临床试验抢救用兽药管理制度"]
[79,null,"B1504","应建立临床试验仪器设备管理制度"]
[80,null,"B1505","应建立临床试验资料管理制度"]
[81,null,"B1506*","应建立兽医防疫制度"]
[82,null,"B1507","应建立饲料及饲料添加剂管理制度"]
[83,null,"B1508","应建立动物疫病监控制度"]
[84,null,"B1509","应建立卫生防疫制度"]
[85,null,"B1510","应建立饲养管理制度"]
[86,null,"B1511","应建立试验动物的隔离观察制度及SOP "]
[87,null,"B1512","应建立饲养区域清洁卫生与消毒制度及SOP"]
[88,null,"B1513","应制定各种仪器、设备操作SOP "]
[89,"B15 兽药临床试验管理制度及SOP","B1514","应制定试验动物筛选与入选SOP "]
[90,null,"B1515","应制定不良事件及严重不良事件处理SOP "]
[91,null,"B1516","应制定严重不良事件报告SOP "]
[92,null,"B1517","应制定试验用兽药接收、保存、分发、回收、返还SOP，并具有可操作性"]
[93,null,"B1518","应制定原始资料归档和保存SOP，并具有可操作性"]
[94,null,"B1519","应制定样本采集、分离、保存、运送和交接SOP "]
[95,null,"B1520","应制定样本特定编码SOP "]
[96,null,"B1521","应建立本项目兽药临床试验动物试验质量保证体系"]
[97,"B16 试验设施与动物的管理\n\n\n\n\n\n\n\n\n\n\n\nB16 试验设施与动物的管理","B1601*","动物试验场所须具备合法的生产营业执照，具有《动物防疫条件合格证》/《实验动物使用许可证》"]
[98,null,"B1602*","租用的动物试验场所的，应签订长期合同。动物试验场变更的应提供通过核查的有关资料"]
[99,null,"B1603*","需要攻毒试验的，应具有与试验项目相符的生物安全设施，试验应符合国家生物安全有关规定"]
[100,null,"B1604*","试验动物饲养设施与所使用的试验动物级别相符合。饲养设施应设计合理、配置适当，布局合理，防止交叉污染（人流、物流、动物流平面布局等）"]
[101,null,"B1605","根据防疫需要一般应有动物隔离舍、兽医室、动物解剖室、无害化处理间等功能间"]
[102,null,"B1606","饲养场周围一定范围内应无其它饲养场、牲畜（活禽）交易市场、屠宰场、生活水源地和居民居住区"]
[103,null,"B1607","应具备排污设备设施和处理措施"]
[104,null,"B1608","应具有清洗消毒设施"]
[105,null,"B1609","试验动物及其产品可供人消费的限制性条件及措施"]
[106,null,"B1610*","应具备收集和处置动物尸体、试验废弃物的设施和无害化处理措施"]
[107,null,"B1611*","对感染性动物试验的动物尸体和组织具备高压灭菌设施和处理措施"]
[108,null,"B1612","饲养设施应能够根据需要调控温度、湿度、空气洁净度、氨浓度、通风和照明等环境条件"]
[109,null,"B1613*","应具有与所承担试验项目相适应的养殖规模,一般应符合以下要求:\n猪存栏500头以上;\n种猪存栏100头以上；\n牛、羊100头以上；\n鸡、鸭5000只以上，其它禽类500只以上；\n兔、水貂、狐狸等原则上不少于500只；\n鱼不少于5000尾；\n其它动物数量根据试验情况确定"]
[110,null,"B1614*","临床试验动物来源、健康检疫证明和资料应完整保存"]
[111,null,"B1615*","试验动物的种类、品系、性别、年龄、体重、营养状况、健康等级等应有相应记录"]
[112,null,"B1616*","观察期对观察项目应做详细记录并保留存档    "]
[113,null,"B1617*","进入饲养区的人员进出应登记记录"]
[114,null,"B1618*","动物的饲料和饮水应定期检验，确保其符合营养和卫生标准"]
[115,null,"B1619","动物的饲料和饮水污染物质的含量应符合国家相关规定"]
[116,null,"B1620*","动物饲料应标明来源、购入日期、效期等并记录"]
[117,null,"B1621*","动物的饲料和饮水定期检验结果作为原始资料保存"]
[118,null,"B1622*","动物饲养室内使用的清洁剂、消毒剂及杀虫剂符合要求(不影响实验结果)，并详细记录其名称、浓度、使用方法和使用的时间等"]
[119,"B17 质量保证实施情况","B1701","临床试验过程应执行各种标准操作规程"]
[120,null,"B1702","应接受监查员的监查并记录在案"]
[121,"B18 试验记录","B1801","试验记录应及时、准确、规范、完整、真实"]
[122,null,"B1802","原始资料应保存完整"]
[123,null,"B1803","兽药临床试验资料应保存至临床试验终止后7年"]
[124,"B19 数据统计与统计分析","B1901","试验总结报告应与试验方案要求一致"]
[125,null,"B1902","试验总结报告内容应符合GCP规定"]
[126,null,"B1903","监查记录应保存完整"]
[127,null,"B1904","数据管理的各种步骤应记录在案"]
[128,null,"B1905","应具有适当的程序保证数据库的保密性"]
[129,"B20 多中心试验","B2001","试验动物的分配应与试验设计确定的方案一致"]
[130,null,"B2002","紧急情况破盲应述明理由"]
[131,null,"B2003","临床试验应遵循多中心统一的兽药临床试验方案"]
[132,null,"B2004","临床试验开始及进行中期应组织或参加试验项目负责人会议"]

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[null,"试验项目名称： "]
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