药物临床试验合同协定内容要点分析

Key Points of the Contract Agreement of Drug Clinical Trial

目的为药物临床试验合同协定内容的拟订提供参考。方法梳理南京医科大学第一附属医院国家药物临床试验机构2014年至2215年签署的742份临床试验合同,细分临床试验合同要素,分析合同中普遍存在的问题,提出解决对策及建议。结果与结论合同存在的问题主要有责任主体不明确、遗传资源约定不完善、探索性研究不合规、经费计算错误。解决对策为,明确受试者赔偿责任、按遗传办要求开展研究、探索性研究需申报伦理并签署合同、公布办事指南、与知情同意书保持一致。建议规范合同审计流程、把控合同审查细节、签署框架合同、建立合理的合同审查制度、实现数据共享。

Objective To provide a reference for the formulation of the conltract agreement of drug clinical tral.Methods A tial of 742 clinical trial contracts signed by the National Dnug Clinical Trial lustitution of the Fist Affiliated Hospital of Nanjing MedicalUniversity from 2014 to 2018 were soted oxut,and the elements of clinical trial contracts were subdivided.The common problems in thecontracts were analyzed,and ecountermeasures and suggestions were put forward.Results and Conclusion The main proMlems of thecontracts are unclear subject of responsibility,imperfect genetic resoures agreement,non-compliance of exploratory research,and wrongcalculation of funds.To solve the probem,we can eclarify the compensation liability of the subjects,carry out research according to therequirements of the genetic office,declare ethics and sign contracts for exploratory research,pubhlish guidelines,and keep consisten withinformed consent.lt is suggested to standardize the process df contract audit,control the details of contract review,sign framework con-tract,formulate reasonable contract review system and share data.