DB43/T 2135-2021 药物临床试验受试者招募管理技术服务规范

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