药物临床试验受试者招募管理技术 服务规范 Drug clinical trial subjects recruitment management technical service specification 发 布 湖南省市场监督管理局43 DB43/T2135—2021 湖南省地方标准 ICS CCS 11.120.99 C 01 2021-08发布-03 2021-10实施-03 DB43/T 2135—2021 I 目 次 前言 ································ ································ ································ ························ Ⅲ 1 范围 ································ ································ ································ ····················· 1 2 规范性引用文件 ································ ································ ································ ······ 1 3 术语和定义 ································ ································ ································ ············ 1 4 缩略语 ································ ································ ································ ·················· 2 5 基本原则 ································ ································ ································ ··············· 2 5.1 知情同意原则 ································ ································ ································ ··· 2 5.2 控制风险原则 ································ ································ ································ ··· 3 5.3 免费和补偿原则 ································ ································ ································ 3 5.4 保护隐私原则 ································ ································ ································ ··· 3 5.5 依法赔偿原则 ································ ································ ································ ··· 3 5.6 特殊保护原则 ································ ································ ································ ··· 3 6 招募组织 /机构 ································ ································ ································ ········ 3 7 受试者招募 ································ ································ ································ ············ 4 7.1 招募方式 ································ ································ ································ ········· 4 7.2 招募流程 ································ ································ ································ ········· 4 8 受试者管理 ································ ································ ································ ············ 5 8.1 依从性管理 ································ ································ ································ ······ 5 8.2 出组后跟踪管理 ································ ································ ································ 5 8.3 人文关怀管理 ································ ································ ································ ··· 5 9 受试者权益和安全 ································ ································ ································ ··· 5 9.1 受试者权益 ································ ································ ································ ······ 5 9.2 受试者隐私保护 ································ ································ ································ 6 10 质量控制 ································ ································ ································ ·············· 6 10.1 数据管理 ································ ································ ································ ······· 6 10.2 评价改进 ································ ································ ································ ······· 6 参考文献 ································ ································ ································ ···················· 7 DB43/T 2135—2021 II DB43/T 2135—2021 III 前 言 本文件按照 GB/T 1.1 —2020《标准化工作导则 第1部分：标准化文件的结构和起草规则》的规 定起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由湖南省药品监督管理局提出并归口。 本文件起草单位：长沙先领医药科技有限公司、中南大学湘雅医院、中南大学湘雅二医院、中南大 学湘雅三医院、湖南省人民医院、湖南省妇幼保健院、湖南省肿瘤医院、湖南省职业病防治院、湖南省 脑科医院、湖南省胸科医院、长沙都正生物科技股份有限公司、长沙市中心医院、长沙市第一医院、长 沙市第三医院、 长沙珂信肿瘤医院、 怀化市第一人民医院、怀化市第二人民医院、 郴州市第一人民医院、 益阳市中心医院、株洲市中心医院、娄底市中心医院、长沙舍同智能科技有责任公司、长沙市药物评价 产业技术创新战略联盟。 本文件主