早期临床试验项目在研究中心病房的管理流程
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摘要
为了保证研究中心临床试验的顺利实施,有效管理早期临床试验项目,需要探索整个试验的管理流程。根据流程化管理理念和试验流程安排,本研究建立了以受试者访视为中心的病房管理流程模式,包括访视前的全方位准备和模拟演练,访视期的受试者、药品、样本、不良事件、数据和文档等管理,访视后药品、样品和数据等管理,全程的质量控制和持续质量改进。该模式目前能够保证临床试验项目的质量,保证受试者依从性和试验完成率。
In order to ensure the smooth conduct of the clinical trials in our research center, the administration process of the whole trial should be explored to manage the early clinical trial programs effectively.Based on the trial workflow and process management theory, the model of ward management centered on subjects' interview was established in this research. The workflow model focused on subject visit with total quality control and continuous quality improvement, including the comprehensive preparation and mock excise before the subject visit, the management of subjects, medicine, sample, adverse events, data and document during the subject visit, and the medicine, sample and data management after the subject visit. Currently this model was conducive to guarantee the quality of clinical trials, subjects' compliance and completion of trials.
In order to ensure the smooth conduct of the clinical trials in our research center, the administration process of the whole trial should be explored to manage the early clinical trial programs effectively.Based on the trial workflow and process management theory, the model of ward management centered on subjects' interview was established in this research. The workflow model focused on subject visit with total quality control and continuous quality improvement, including the comprehensive preparation and mock excise before the subject visit, the management of subjects, medicine, sample, adverse events, data and document during the subject visit, and the medicine, sample and data management after the subject visit. Currently this model was conducive to guarantee the quality of clinical trials, subjects' compliance and completion of trials.
引文
[1]张田香,陆明莹,陈明伟,等.从机构办公室角度谈药物临床试验的质量控制[J].中国新药与临床杂志,2014,33(6):429-431.
[2]方芳.国内临床试验项目管理初探[J].中国新药杂志,2014,23(8):885-888.
[3]蒋发烨,吴一龙,余细勇,等.药物临床试验机构对临床试验的组织管理和质量控制[J].医药导报,2011,30(3):400-402.
[4]李海燕,吉萍.《药物临床试验质量管理规范》(GCP)在临床研究中的价值及我国研究者的依从情况[J].北京大学学报:医学版,2010,42(6):637-640.
[5]王杰松,刘刚,吴久鸿.药物临床试验的风险与管理[J].中国药房,2008,19(31):2407.
[6]林颖,周谏开.关于加强临床试验招募广告伦理审查的探讨[J].中国处方药,2014,12(9):1-3.
[7]卢根娣,张鹭鹭.药物临床试验中受试者的依从性管理[J].解放军医院管理杂志,2008,15(3):293-295.
[8]张冬林,刘东,方淑贤,等.新药Ⅰ期临床试验过程中受试者的安全问题与管理[J].医药导报,2009,28(3):389-390.
[9]曹烨,葛洁莹,岑华芳,等.临床研究助理/研究护士角色定位、职责与管理模式[J].中国新药与临床杂志,2017,36(11):647-652.
[10]孙美艳,卢洪洲.药物临床试验机构研究护士的角色、资质要求及职责[J].护理研究,2014,28(8):2910-2911.
[11]CHUNHUA WENG,YU LI,SOLOMON BERHE,et al.An integrated model for patient care and clinical trials(IMPACT)to support clinical research visit scheduling workflow for future learning health systems[J].J Biomed Inform,2013,46(4):642-652.
[2]方芳.国内临床试验项目管理初探[J].中国新药杂志,2014,23(8):885-888.
[3]蒋发烨,吴一龙,余细勇,等.药物临床试验机构对临床试验的组织管理和质量控制[J].医药导报,2011,30(3):400-402.
[4]李海燕,吉萍.《药物临床试验质量管理规范》(GCP)在临床研究中的价值及我国研究者的依从情况[J].北京大学学报:医学版,2010,42(6):637-640.
[5]王杰松,刘刚,吴久鸿.药物临床试验的风险与管理[J].中国药房,2008,19(31):2407.
[6]林颖,周谏开.关于加强临床试验招募广告伦理审查的探讨[J].中国处方药,2014,12(9):1-3.
[7]卢根娣,张鹭鹭.药物临床试验中受试者的依从性管理[J].解放军医院管理杂志,2008,15(3):293-295.
[8]张冬林,刘东,方淑贤,等.新药Ⅰ期临床试验过程中受试者的安全问题与管理[J].医药导报,2009,28(3):389-390.
[9]曹烨,葛洁莹,岑华芳,等.临床研究助理/研究护士角色定位、职责与管理模式[J].中国新药与临床杂志,2017,36(11):647-652.
[10]孙美艳,卢洪洲.药物临床试验机构研究护士的角色、资质要求及职责[J].护理研究,2014,28(8):2910-2911.
[11]CHUNHUA WENG,YU LI,SOLOMON BERHE,et al.An integrated model for patient care and clinical trials(IMPACT)to support clinical research visit scheduling workflow for future learning health systems[J].J Biomed Inform,2013,46(4):642-652.