T/SDLPA 0001-2024 研究型病房建设和配置标准

ICS11.020

CCSC00

SDLPA

团体标准

T/SDLPA0001—2024

研究型病房建设和配置标准

Constructionandequipmentstandardofresearchwards

2024-05-31发布2024-05-31实施

山东省药师协会发布

T/SDLPA0001—2024

目次

前言..........................................................................III

1概述................................................................................1

2目的................................................................................1

3适用范围............................................................................1

4规范性引用文件......................................................................1

5术语及定义..........................................................................1

5.1研究型病房Researchward.........................................................1

5.2临床试验研究Clinicaltrialresearch..................................................2

6缩略语..............................................................................2

7资质与备案管理......................................................................2

7.1医疗机构资质要求................................................................2

7.2研究型病房要求..................................................................2

8病房建设............................................................................2

8.1筛选区的建设....................................................................2

8.2研究药房的建设..................................................................3

8.3资料储存区的建设................................................................3

8.4试验区的建设....................................................................3

8.5受试者活动区/室、餐厅...........................................................4

8.6办公区的建设....................................................................4

8.7生物样本处置区的建设............................................................5

9人员配置............................................................................5

9.1研究型病房负责人................................................................5

9.2主要研究者（临床研究负责人）....................................................5

9.3研究医生........................................................................5

9.4研究护士........................................................................6

9.5药师............................................................................6

9.6样本管理员......................................................................6

9.7质控员..........................................................................6

9.8其他研究人员....................................................................6

10管理制度...........................................................................6

10.1保障健康与安全的管理制度.......................................................6

10.2研究型病房考核管理制度.........................................................6

10.3人员培训管理制度...............................................................7

10.4人员考核晋升制度...............................................................7

10.5科技经费管理制度...............................................................7

10.6项目运行管理制度...............................................................7

10.7临床研究项目负责人制度.........................................................7

I

T/SDLPA0001—2024

10.8医、研、企人才互聘制度.........................................................7

11信息化的建设.......................................................................7

12质量控制...........................................................................8

参考文献........................................................................9

II

T/SDLPA0001—2024

前言

本文件按照GB/T1.1