Ⅰ期临床试验病历记录要求与书写规范实践共识  

The Practice Consensus on Requirement and Writing Standard for Medical Records of PhaseⅠClinical Trials

作　　者：许重远[1] 潘芸芸 贺晴 陈勇川 沈一峰[4] 王美霞 吴国兰[6] 曾星[7] 钟国平[8] 温预关[9] 游广智 徐平声[11] XU Zhongyuan;PAN Yunyun;HE Qing;CHEN Yongchuan;SHEN Yifeng;WANG Meixia;WU Guolan;ZENG Xing;ZHONG Guoping;WEN Yuguan;YOU Guangzhi;XU Pingsheng(Clinical Pharmacy Center,Nanfang Hospital,Southern Medical University,Guangdong Guangzhou 510515,China;Beijing Boren Hospital,Beijing 100070,China;The Southwest Hospital of AMU,Chongqing 400037,China;Shanghai Mental Health Center,Shanghai 201109,China;Beijing Jishuitan Hospital,Beijing 100035,China;The First Affiliated Hospital,Zhejiang University School of Medicine,Zhejiang Hangzhou 310003,China;Guangdong Provincial Hospital of Chinese Medicine,Guangdong Guangzhou 510120,China;School of Pharmaceutical Sciences,Sun Yat-Sen University,Guangdong Zhongshan 528478,China;The Affiliated Brain Hospital of Guangzhou Medical University,Guangdong Guangzhou 510370,China;Queen Mary Hospital,Hongkong 999077,China;Xiangya Hospital,Central South University,Hunan Changsha 410008,China)

机构地区：[1]南方医科大学南方医院临床药学中心,广东广州510515 [2]北京高博博仁医院,北京100070 [3]陆军军医大学第一附属医院,重庆400037 [4]上海市精神卫生中心,上海201109 [5]北京积水潭医院,北京100035 [6]浙江大学医学院附属第一医院,浙江杭州310003 [7]广东省中医院,广东广州510120 [8]中山大学药学院,广东中山528478 [9]广州医科大学附属脑科医院,广东广州510370 [10]香港大学玛丽医院,中国香港999077 [11]中南大学湘雅医院,湖南长沙410008

出　　处：《中国医药导刊》2023年第10期979-982,共4页Chinese Journal of Medicinal Guide

摘　　要：为规范Ⅰ期临床试验病历的书写,有效保障临床试验中采集的数据可溯源,加强源数据受控管理,提高Ⅰ期临床试验的研究效率与质量,保护受试者/参与者的权益与安全,“中国临床研究能力提升与受试者保护”高峰论坛(CCHRPP)组建行业专家团队,根据《药物临床试验质量管理规范》《药品注册核查要点与判定原则(试行)》等相关规定,参照《病历书写基本规范》《医疗机构病历管理规定(2013年版)》《电子病历应用管理规范(试行)》等规范,结合实践共同起草、审核并制定《Ⅰ期临床试验病历记录要求与书写规范实践共识》。本共识适用于Ⅰ期临床试验,明确:①具备电子数据采集系统条件时,受试者/参与者相关检验检查数据以临床试验机构医院信息系统(HIS)、实验室信息管理系统(LIS)、影像归档和通信系统(PACS)等信息系统数据为源数据,涵盖试验筛选期、入组、给药、样本采集与处理、安全性观察与随访/随诊等全过程数据实时采集的原始记录为源文件;②不具备电子数据采集系统条件时,采用受控的纸质病历与电子病历系统相结合的方式记录试验过程。纸质记录包括知情同意书、装订成册的纸质病历、原始记录表格(药物管理表、血样采集表、样本处理表)等,需受控管理,表格进行版本控制。本共识旨在为Ⅰ期临床试验病历的书写提供实践参考。人体生物利用度或生物等效性研究可参照本共识。In order to standardize the writing of medical records of PhaseⅠclinical trials,effectively ensure the traceability of data collected in clinical trials,strengthen the controlled management of source data,improve the research efficiency and quality of PhaseⅠclinical trials,and protect the rights and safety of subjects/participants,China Forums of Clinical Research Capacity Building and Human Research Participants Protection(CCHRPP)set up a team of experts,according to the“Good Clinical Practice”,“Drug Registration Verification Points and Judgment Principles(Trial)”and other relevant provisions,referring to the“Basic Standards for Medical Record Writing”,“Medical Record Management Regulations for Medical Institutions(2013 edition)”,“Standards for Electronic Medical Record Application Management(Trial)”and other norms,jointly draft,review and formulate the“Practice Consensus on Requirement and Writing Standard for Medical Records of PhaseⅠClinical Trials”in accordance with practice.This consensus is applicable to PhaseⅠclinical trials and clarifies:①When electronic data acquisition system is available,the relevant examine data of the subjects/participants should be collected from the hospital information system(HIS),laboratory information management system(LIS),picture archiving and communication system(PACS)and other information systems of clinical trial institutions as the source data,covering the whole process data of trial screening period,enrollment,drug administration,sample collection and processing,safety observation and follow-up;②When no electronic data acquisition system is available,the controlled paper medical record combined with the electronic medical record system should be used to record the test process.Paper records include informed consent,bound paper medical records,original record forms(drug management form,blood sample collection form,sample processing form,etc.),which need to be controlled and managed,and the form is subject to version control.This consens

关 键 词：Ⅰ期临床试验 病历记录 书写规范 实践共识 

分 类 号：R97[医药卫生—药品]