关键词: 临床试验, 试验方案, 标准操作规程, 数据管理, 质量保证

Abstract: Key trial activities include:development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study:recruitment,eligibility,and informed consent;the investigational product (s):quality,handling,and accounting;trial data acquisition:conducting the trial;trial data acquisition:conducting the trial;safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.

Key words: clinical research, trial protocol, standard operating procedures, managing trial data, quality assurance