DB43/T 2135-2021 药物临床试验受试者招募管理技术服务规范
DB43/T 2135-2021 Drug clinical trial participant recruitment management technical service specification
基本信息
发布历史
-
2021年08月
研制信息
- 起草单位：
- 起草人：
- 出版信息：
- 页数：13页 | 字数：- | 开本： -
内容描述
ICS11.120.99
CCSC01
43
湖南省地方标准
DB43/T2135—2021
药物临床试验受试者招募管理技术
服务规范
Drugclinicaltrialsubjectsrecruitmentmanagement
technicalservicespecification
2021-08-03发布2021-10-03实施
湖南省市场监督管理局发布
DB43/T2135—2021
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·····································································································
定制服务
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