浅谈Ⅰ期临床试验受试者招募筛选信息管理系统的使用

A superficial discussion on the application of the information management system for subjects recruited and screened for phaseⅠclinical trial

目的:介绍上海市徐汇区中心医院临床试验研究中心的Ⅰ期临床试验受试者招募筛选信息管理系统的功能和实际应用。方法:该系统利用人体的重要生物特征指纹,并配合身份证的验证和近照的比对,能快速、准确地发现不符合试验要求的受试者。结果和结论:目前已经建立405例健康受试者的信息记录。受试者信息电子化提高了筛选的效率,节约人力资源和时间,方便研究者对受试者进行管理,保证临床试验的质量。

Objective： To introduce the function and practical application of the information management system for sub jects recruited and screened for phase I clinical trial in the Central Hospital of Shanghai Xubui District. Methods： Finger prints, as an important biological feature of the human body, could be used in the system to find quickly and accurately unsuita ble subjects for clinical trials. Results and Conclusion： Now, an information record of 405 healthy subjects has been established. Electronization of subject information could substantially increase working efficiency, save human resources and time, enable researchers to have better management of subjects, and most importantly ensure the quality of clinical trials.