新版GCP下临床试验电子病历系统的建设与实践

Construction and Implementation of Clinical Trial Electronic Medical Record System According to the New Version of GCP

临床试验病历是记录药物临床试验过程的重要材料,是数据溯源的重要依据。临床试验随访过程中仍存在纸质病历,其在可用性等方面有着诸多局限,已不能满足临床试验对于数据质量的要求。本文探讨在医院信息系统(hospital information system,HIS)电子病历的基础上,根据公认的质量标准建设临床试验电子病历并将其嵌入HIS系统,实现非门诊就诊、非住院患者的病历电子化;部署电子签名系统,保证其安全性和可溯源性;设计病历模板,在符合医院病历书写要求的同时,保证临床试验需要的信息记录完整。

Medical records of clinical trial are important materials to record the process of clinical trial,and also are the foundation of source document verification.However,paper medical record still exists in the follow-up process of clinical trial,which has many limitations in usability and other aspects that cannot meet the requirements of data quality in clinical trial.Based on the electronic medical record system of the Hospital Information System(HIS),the current study discussed the construction of clinical trial electronic medical record according to the recognized quality standards and embedded it into HIS,so as to establish the electronic medical record system of non-outpatient and non-inpatient patients.The system has included electronic signature systems to ensure security and traceability,designed medical record template to meet the requirements for hospital medical records,while ensuring the integrity of information records for clinical trials.