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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

湖南省地方标准 简体中文 现行 页数：11页 | 格式：PDF

基本信息

标准号
DB43/T 2896-2023
标准类型
湖南省地方标准
标准状态
现行
中国标准分类号（CCS）
C01 技术管理
国际标准分类号（ICS）
11.120.99 有关制药学的其他标准
发布日期
2023-12-20
实施日期
2024-03-20
发布单位/组织
湖南省市场监督管理局
归口单位
-
适用范围
-

发布历史

文前页预览

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-第1页
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-第2页
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-第3页

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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