临床试验研究人员资质管理系统设计与应用

Design and Application of the Management System of Clinical Trial Investigator Qualification

目的为临床试验研究人员资质的信息化管理提供参考。方法分析医院临床试验研究人员资质管理现存问题,以医院人力资源一体化管理平台软件为基础,进一步开发用于研究人员资质管理的药物临床试验质量管理规范(GCP)模块,构建相应管理系统,评价系统使用效果。结果目前,大多数医院临床试验研究人员资质文件管理工作量大,操作烦琐,且信息更新不及时,不利于实际工作的开展及配合相关部门现场核查。该研究中所建研究人员资质管理系统与医院人事科实现信息和资源共享,与新系统应用前比较,应用后研究人员提供资质文件需时由10 min缩短至0 min(可忽略),临床研究协调员收集研究人员资质文件需时由10 h缩短至1 h,资质文件差错率由30%降至0,机构审核研究人员资质需时由1 h缩短至0 min(审核前置,可忽略)。截至2022年6月1日,已有431名研究人员上传专业资格信息,其中医师223名、护士188名、药师8名、技师12名;收集到GCP培训证书788份,以2021年最多(292份)。结论该系统切实提高了医院对临床试验研究人员资质管理的水平和效率,系统中相应信息更新及时,时效性强且无安全隐患。机构管理人员通过该系统可快速、准确查找及统计信息,为实现研究人员信息的数字化管理提供了新思路。

Objective To provide a reference for the informatization management of clinical trial investigator qualification.Methods The existing problems in the management of clinical trial investigator qualification in hospitals were analyzed,the Good Clinical Practice(GCP)module for the qualification management of investigators was established based on the integrated management platform software for hospital human resources,in order to construct a corresponding management system,and the effect of the system was evaluated.Results Currently,most hospitals had a large workload in the management of clinical trial investigator qualification documents,which was cumbersome to operate,and the information was not updated timely,which was not conducive to the implementation of actual work and coordination with relevant departments for on-site verification.The established investigator qualification management system in the study realized the sharing of information and resources with the personnel department of the hospital.Compared with those before the application of the new system,the time required for investigators to provide qualification documents after the application was reduced from 10 min to 0 min(the time required was negligible),the time required for clinical research coordinators(CRC)to collect investigator qualification documents was reduced from 10 h to 1 h,the error rate of qualification documents was reduced from 30%to 0,and the time required for institutions to review investigators qualification documents was reduced from 1 h to 0 min(pre-review,the time required was negligible).As of June 1,2022,431 investigators had uploaded professional qualification information,including 223 physicians,188 nurses,8 pharmacists,and 12 technicians.A total of 788 GCP training certificates were collected,with a maximum of 292 certificates in 2021.Conclusion The system has effectively improved the level and efficiency of clinical trial investigator qualification management in hospitals.The corresponding information in the system is updated timely,with strong timeliness and no potential safety hazards.Through this system,institutional managers can quickly and accurately search and collect information,which can provide a new idea for achieving digital management of investigators′information.