DB43/T 2896-2023 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
DB43/T 2896-2023 Drug clinical trial major investigator practice training base construction and operation management specifications
基本信息
发布历史
-
2023年12月
研制信息
- 起草单位：
- 起草人：
- 出版信息：
- 页数：11页 | 字数：- | 开本： -
内容描述
ICS11.120.99
CCSC01
43
湖南省地方标准
DB43/T2896—2023
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
Constructionandoperationmanagementstandardsof
practicaltrainingbasesforprincipalinvestigator
ofdrugclinicaltrials
2023-12-20发布2024-03-20实施
湖南省市场监督管理局发布
DB43/T2896—2023
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·······································
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