临床研究协调员相关医院感染风险现况问卷调查  

Questionaire survey of prevalence and risk of nosocomial infection in clinical research coordinators

作　　者：阮燕萍[1] 吕文波 徐艳[2] 王亚[1] RUAN Yan-ping;LYU Wen-bo;XU Yan;WANG Ya(Zhejiang Cancer Hospital,Institute of Basic Medicine and Cancer(IBMC),Chinese Academy of Sciences,Hangzhou,Zhejiang 310022,China)

机构地区：[1]浙江省肿瘤医院,中国科学院基础医学与肿瘤研究所医院感染管理部,浙江杭州310022 [2]浙江省肿瘤医院,中国科学院基础医学与肿瘤研究所医院GCP中心,浙江杭州310022

出　　处：《中华医院感染学杂志》2023年第14期2195-2199,共5页Chinese Journal of Nosocomiology

基　　金：浙江省基础公益研究计划基金资助项目(LQ20H260002)。

摘　　要：目的了解医院内临床研究协调员(CRC)的工作与医院感染之间的关系,正确评估CRC相关医院感染风险,防范医院感染发生。方法自行编制CRC相关医院感染风险调查表,于2022年3月8日-10日采用问卷星对在浙江省三甲医院工作的253名临床研究协调员进行调查,调查内容包括人员基本信息、项目管理情况、器械管理相关情况、标本管理相关情况和疫情防控内容。结果253名CRC来自30家不同的临床试验现场管理公司(SMO),以年轻女性、药相关本科专业为主,有56.92%需跨病区/科室工作,有8.7%需跨医院工作。管理项目以注册药物临床试验为主,占92.89%。有134人(52.96%)需要管理医疗器械,主要是一次性无菌耗材,有个别器械需送供应室灭菌;无菌医疗器械的存放及使用未完全按要求统一管理。有189人(74.70%)需要处置管理标本。86.17%的CRC需要接触患者。98.02%的CRC自行清洗工作服,清洗频率为(11±12.3)d。结论临床试验实施过程中有可能存在CRC自身、医疗器械及标本管理方面等引发的医院感染风险,医院须及时识别感染风险,将CRC纳入统一管理和培训,加强临床试验全过程的人员、器械、标本的规范管理,防范医院感染的发生。OBJECTIVE To investigate the relationship between work of clinical research coordinators(CRCs)and nosocomial infection and correctly assess the risk of nosocomial infection in the CRCs so as to prevention the nosocomial infection.METHODS The self-programmed questionnaire was employed to analyze the risk for nosocomial infection in the CRC.Totally 253CRCs who worked in a province-level three-A tertiary hospital were investigated by using questionnaire star from Mar 8,2022to Mar 10,2022.The contents of the survey included basic information of CRCs,project management,specimens management and epidemic control.RESULTS The 253CRCs came from 30site management organizations(SMOs),most of whom were female and majored in medicine of bachelor’s degree.56.92%of the CRCs needed to work across wards/departments,and 8.7%needed to work across hospitals.The registration of clinical trial for drugs was dominant among the management items,accounting for 92.89%.Totally 134(52.96%)CRCs needed to manage medical devices,most of which were disposable sterile supplies,several types of devices needed to be delivered to central sterile supply department for sterilization.The storage and use of the sterile medical devices failed to be managed under the requirement.189(74.70%)CRCs needed to dispose and manage the specimens.86.17%of the CRCs need to contact patients.98.02%of the CRCs needed to clean work clothes by themselves,with the cleaning frequency(11±12.3)days.CONCLUSION The nosocomial infection may be caused by CRCs themselves and management of medical devices and specimens during the process of clinical trial.It is necessary for the hospital to identify the risk for infection,bring the CRCs into the unified management and training,and strengthen the standardized management of personal,devices and specimens during the whole process of clinical trial so as to prevent the nosocomial infection.

关 键 词：临床试验 临床研究协调员 医院感染 风险评估 管理 问卷调查 

分 类 号：R197.32[医药卫生—卫生事业管理]