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

ICS

.120.9CCS

C

43湖 南 省 地 方 标 准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Construction

and

operation

management

standards

ofpractical

training

bases

for

principalinvestigatorof

drug

clinicaltrials2023

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12

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20

发布

2024

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-

实施湖南省市场监督管理局

发

布DB43/T

— 前言························································································································

Ⅲ1

·····················································································································12

规范性引用文件······································································································13

术语和定义············································································································14

缩略语··················································································································25

建设资质···············································································································26

设施设备···············································································································27

师资条件···············································································································38

培训体系···············································································································39

运营管理···············································································································39.1 进修信息发布···································································································39.2进修审核与管理································································································

39.3进修培训·········································································································49.4 考核···············································································································49.5 信息管理·········································································································410 质量评价与改进

····································································································410.1质量监督检查

·································································································410.2 评价方式与内容

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

510.3持续改进

·······································································································5DB43/T

— 本文件按照

GB/T

—《标准化工作导则 第

1

部分：标准化文件的结构和起草规则》的规定起草。请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。本文件由湖南省药品监督管理局提出并归口。学附属第一医院、南华大学附属第二医院、怀化市第一人民医院、娄底市中心医院、湘潭市中心医院、岳阳市人民医院。华、孙学雄、刘靖、朱芳、张静、刘黎。IIDB43/T

—1

运营管理、质量评价与改进等要求。本文件适用于药物临床试验主要研究者实践培训基地的建设与运行管理。2

规范性引用文件文件。DB43/T

2135—2021药物临床试验受试者招募管理技术服务规范3

术语和定义3.1

下列术语和定义适用于本文件。药物临床试验机构 drug

clinical

trial

（

GCP（求，开展药物临床试验的机构。[来源：DB43/T

2135—，3.1]3.2临床试验 clinical

trial的系统性试验。[来源：DB43/T

2135—，3.2]3.3主要研究者principal

实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场负责人。[来源：DB43/T

2135—，3.3]3.4主要研究者实践培训基地 principal

practical

training

符合相关条件，可为主要研究者提供药物临床试验理论与实践培训服务的药物临床试验机构。3.5进修人员

取得

DB43/T

—研究者。3.6标准操作规程

operating

为保证某项特定操作一致性而制定的详细书面要求。3.7不良事件adverse

events常，但不一定与试验用药品有因果关系。3.8严重不良事件

events治疗或者延长住院时间，以及先天性异常或者出生缺陷等不良医学事件。3.9可疑且非预期严重不良反应

suspected

unexpected

serious

adverse

已有资料信息的可疑并且非预期的严重不良反应。4

缩略语下列缩略语适用于本文件。GCP:药物临床试验质量管理规范（Good

Clinical

Practice）PI:主要研究者

Investigator)AE:不良事件（

）SAE:严重不良事件（

Adverse

Events）SUSAR:可疑且非预期严重不良反应（Suspected

Reaction）基地：主要研究者实践培训基地

（Principal

Investigator

Practical

Training

Base）5

建设资质基地建设资质应符合以下要求：——在国家药物临床试验机构平台备案；——正常运行至少

3

年；——备案专业数至少

5

——启动非同类型同专业项目数至少

5

个/——通过国家项目核查数至少

5

个；——实施注册类临床项目数至少

20

个；——无违法记录。6

设施设备基地设施设备应符合以下要求：——应符合

GCP

法规要求；DB43/T

———应有独立办公场所且配套设施齐全；——应有临床试验培训场所，具备开展临床试验项目的条件。7

师资条件7.1 基地主要负责人应符合以下条件：——本科以上学历；——应具备医药相关专业背景；——具有相关管理工作经验；——无违法违规记录。7.2 基地带教导师应符合以下条件：——应为

；——应具有相关部门组织的临床试验项目监督、检查工作经验；——无违法违规记录；——基地至少配备

3

名专（兼）职管理人员，并持有

GCP

证书。8

培训体系8.1 基地应建立覆盖药物临床试验全过程的管理制度和标准操作规程，定期修订且不断完善。8.2

基地应制定各岗位人员的岗位职责并实施培训，内容包括但不限于职业道德、相关政策法规及管理服务技能等。8.3 基地应建立进修人员培训管理制度。8.4 基地应建立进修人员理论培训和实践培训课程体系。8.5 基地应建立防范和处理药物临床试验中突发事件的管理机制与应急预案。9

运营管理9.1进修信息发布基地应及时公开相关信息，内容至少应包括：——营业执照；——地理位置；——进修流程；——设施设备概况；——主要服务项目情况；——投诉途径。9.2 进修审核与管理基地进修审核与管理，应包含以下内容：——基地审核并收集报名信息，公示录取名单并发送培训通知书，告知报到流程及要求；——基地应有专人负责收集、更新和公示各类服务信息，确保信息的准确、完整和安全；DB43/T

—务、合同变更与解除，违约责任、争议解决方式等；——基地应根据进修人员情况指定带教导师；——基地应制定培训计划并建立沟通汇报机制，便于进修人员提前了解进修安排及反馈进修成果。9.3进修培训9.3.1 进修培训应包括理论培训与实践培训。9.3.2 理论培训应包括以下内容：——

法规；——

工作职责；——临床试验流程；——临床方案设计原则；——

记录及判定原则；——

及

SUSAR

处理及上报流程等内容。9.3.3实践培训应涵盖临床试验全流程，应至少参与授权

3

项注册临床试验项目相关工作，每个项目授权时间至少

1

个月。内容包括立项准备阶段、实施阶段、结题阶段：——立项准备阶段。了解并熟悉项目立项资料审核要点、方案设计要点、科室评估能力评估要点、伦理资料提交流程、临床试验合同管理要点，至少参加

1

次伦理审查会；点、伦理委员会沟通注意事项等，不应为研究医生、研究护士及

；——结题阶段。了解并熟悉项目小结、总结报告撰写流程及要点，项目结题流程。9.4考核9.4.1基地负责组织考核，包含理论考核、实践考核和结业考核。9.4.2 理论考核包含以下内容：——应以闭卷形式组织考核；——不及格者应组织重新学习，允许补考

1

——补考不及格者，应延长培训时间或取消培训资格。9.4.3 实践考核应有具体的实践考核记录。日常汇报由导师根据学员参与的具体工作表现进行评估。9.4.4 结业考核应在理论学习考核及实践学习考核均通过后进行，包含以下内容：——结业考核应以现场问答模式进行，评委现场打分；——结业考核通过后，应收集

3

个注册性临床研究的授权表以及进修证，基地发放证书。9.5信息管理基地应建立进修人员培训档案，推荐采用信息化进行数据管理。10

质量评价与改进10.1 质量监督检查10.1.1 应建立基本服务、管理的相关制度和流程。10.1.2 应建立质量考核制度，制定各岗位考核细则。DB43/T

—10.1.3应采用多种方式，不定期检查服务质量，发现问题及时整改。10.2 评价方式与内容10.2.1 评价方式分为自我评价和第三方评价。10.2.2 自我评价的内容与方法应符合以下要求：——应向进修人员开展满意度测评，测评至少每年

1

次；——每年应对制度、流