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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2018年第2期81-87,共7页
Chinese Journal of New Drugs and Clinical Remedies
基金
北京市科委课题"重大项目科技成果转化落地培育"项目-肿瘤药物临床评价关键技术平台建设基金资助项目(Z111100059411059)
北京市留学人员科技活动择优资助经费(2014ZYZZ1)
首都医科大学附属北京市世纪坛医院科研课题(2013-q05)
关键词
临床试验
Ⅰ期
医学科学研究中心
质量控制
全面质量管理
clinical trial, phase I
academic medical centers
quality control
total quality management
