临床试验中实现受试者诊疗过程信息化管理的探索与实践

Exploration and practice of information management in the diagnosis and treatment process in clinical trials

目的探索临床试验开展过程中对受试者诊疗过程的信息化管理方法,提升临床试验效率及质量,确保临床试验的开展符合现行版《药物临床试验质量管理规范》。方法2021年起,笔者在海南省人民医院医院信息系统(HIS)中对临床常规诊疗流程根据临床试验开展需求进行功能改造,探索实践内容包括建立临床试验集中随访诊区模块、项目字典库及对应的记账结算方式、研究者及受试者信息关联试验项目、专用电子病历模板、自动生成相应查询报表等。结果实现受试者在就诊随访中相关诊疗医嘱的信息化开具、执行及结算,并与普通诊疗相关医嘱区分。结论通过实践临床试验相关诊疗操作的信息化管理,解决由于多科室合作、多人员参与、多项目并举的特点带来的诸多困难,使管理流程更加规范,推动临床试验的合规高效实施。

Objective To explore the information management in the diagnosis and treatment process of subjects in clinical trials,improve the efficiency and quality of clinical trials,and ensure that clinical trials are conducted in compliance with the current version of the“Good Clinical Practice”.Methods Since 2021,functional modifications were made in the clinical routine diagnosis and treatment process in the Hospital Information System(HIS)of Hainan General Hospital according to the needs of clinical trials,including establishing clinical trial centralized follow-up area module,project dictionary library,and the corresponding accounting settlement method,researchers and subjects information-related trial project,specialized electronic medical record template,automatically generated corresponding query reports,etc.Results The information-based issuance,execution,and settlement of relevant medical orders for diagnosis and treatment of subjects during follow-up visits were realized,to distinguish from medical orders related to general diagnosis and treatment.Conclusion Through the practice of information management of diagnosis and treatment operations related to clinical trials,many difficulties brought by the characteristics of multi-department cooperation,multi-personnel participation and multi-projects are solved,so that the management process is standardized and the compliance and efficient implementation of clinical trials are promoted.