浅谈药物临床试验机构对监查员履职的监管模式

Supervision Mode of Drug Clinical Trial Institutions on the Performance of Supervisors

目的:加强药物临床试验机构对监查员履职的监管。方法:监查员开展监查活动前,对其资质进行审核,考核其对已批准方案、法规等的熟悉程度,审核监查计划。监查员开展临床试验活动时,从试验启动前、试验进行阶段、试验结题三个阶段进行量化监管,对监查员、申办者或合同研究组织进行黑白名单管理。结果:大部分监查员能积极配合机构的监管工作,较好地控制了临床试验质量,但仍有部分监查员不配合机构监管工作且不能有效履职。结论:我院药物临床试验机构监查员履职的监管模式具有推广价值,但仍需持续改进优化。

Objective:To strengthen the supervision of drug clinical trial institutions on the performance of supervisors.Methods:Before carrying out the supervision activities,the qualifications of the supervisors would be reviewed,the familiarity with the approved schemes and regulations would be assessed and the supervision plans would be checked.When carrying out clinical trial activities,the quantitative supervision from three stages,namely,before the start of the trial,during the trial and at the end of the trial would be supervised,and the black and white list management for the supervisors,the sponsor or the contract research organization were conducted.Results:Most of the supervisors can actively cooperate with the regulatory work of the institution and better control the quality of clinical trials,yet there were still some supervisors who do not cooperate with the regulatory work of the institution and cannot perform their duties effectively.Conclusion:The drug clinical trial institution of our hospital has a good promotion and application value for the supervision mode of supervisors,but it still needs to optimize the supervision mode of supervisors.