DB43/T—2023 289643 湖南省地方标准 ICS 11.120.9 CCS C 019 发 布 湖南省市场监督管理局2023-1 2发布-20 2024-03实施-2 0药物临床试验主要研究者实践培训 基地建设与运行管理规范 Construction and operation management standards of practical training bases for principal investigator of drug clinical trials DB43/T 2896—2023 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 建设资质 ································ ································ ································ ··············· 2 6 设施设备 ································ ································ ································ ··············· 2 7 师资条件 ································ ································ ································ ··············· 3 8 培训体系 ································ ································ ································ ··············· 3 9 运营管理 ································ ································ ································ ··············· 3 9.1 进修信息发布 ································ ································ ································ ··· 3 9.2 进修审核与管理 ································ ································ ································ 3 9.3 进修培训 ································ ································ ································ ········· 4 9.4 考核 ································ ································ ································ ··············· 4 9.5 信息管理 ································ ································ ································ ········· 4 10 质量评价与改进 ································ ································ ································ ···· 4 10.1 质量监督检查 ································ ································ ································ · 4 10.2 评价方式与内容 ································ ································ ······························ 5 10.3 持续改进 ································ ································ ································ ······· 5