北京市药物临床试验合同共识(2024 年).pptx

北京市药物临床试验合同共识

（2024年）

一、申办者职责·········································································································3

二、研究者职责··········································································································4

三、保险和损害补偿·································································································6

四、知识产权··············································································································8

五、形成的共识如下·································································································9

（一）合同的主要内容·······························································································9

（二）申办者职责·····································································································9

（三）研究者职责···································································································10

（四）保险和损害补偿·····························································································11

（五）知识产权······································································································12

1北京市药物临床试验合同共识（2024年）

药物临床试验，指以人体（患者或健康受试者）为对象的试验，意在发现或验证某

种试验药物的临床医学、药理学以及其他药效学作用、不良反应，或者试验药物的吸收、分布、代谢和排泄，以确定药物的疗效与安全性的系统性试验。由于药物研发单位（如药企、研究所等）不一定具备实施试验药物的临床条件和资质，所以临床试验需要申办者和/或其代理机构，如临床试验合同研究组织（以下简称CRO），临床试验机构及主要研究者（以下简称研究者）以及受其委托和管理的临床试验现场管理组织（以下简称SMO）及其派遣的临床试验协调员（以下简称CRC）等临床试验相关方的通力合作。药物临床试验相关的合同是申办者与临床试验机构及研究者等临床试验参与方专门针对特定药物临床试验项目中特定任务所签订的协议，它是上述临床试验参与方约定各方职责、权益，明确临床试验经费、支付，和/或纠纷解决等等的重要文件之一。

药物临床试验相关的合同应遵循《中华人民共和国民法典》《中华人民共和国药品

管理法》《中华人民共和国疫苗管理法》《中华人民共和国个人信息保护法》《中华人民共和国人类遗传资源管理条例》《人类遗传资源管理条例实施细则》《药品注册管理办法》《药物临床试验质量管理规范》（以下简称GCP）《药品生产质量管理规范（2010年修订）-临床试验用药品（试行）附录》（以下简称GMP-临床试验用药品附录）《药物临床试验期间安全性数据快速报告标准和程序》、国际人用药品注册技术协调会（以下简称ICH）发布的相关指南及反商业贿赂等其他适用的法律法规、行业技术准则的规定，并受其保护；同时需要按照具体临床试验方案、知情同意书及其他关键性试验文件来制定。在符合上述规定的前提下，结合具体临床试验的需要，药