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

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·······································