临床试验机构研究者标准操作规程

Standard operating procedures for investigators in institution of clinical trial

依据SFDA《药品临床试验管理规范》 ,ICHGCP ,WHOGCP ,以及我院临床试验的实践 ,制订临床试验机构研究者的标准操作规程 ,包括研究者资格与条件 ,试验前的准备 ,受试者的招募和筛选 ,受试者的知情同意 ,方案的依从性 ,受试者的医疗 ,随机化程序和破盲 ,安全性报告 ,源文件和源数据 ,病例报告表 ,试验用药的管理 ,试验的终止或暂停 ,进展报告和总结报告 ,档案等。

Standard Operating Procedures (SOP) of clinical investigators are established according to SFDA, ICH and WHO Good Clinical Practice standards, and experiences of clinical trials practice in our hospital. It includes qualification and competence of investigators, prior to initiation of the study, screening and recruitment of study subjects, obtain informed consent from all trial subjects, protocol compliance, provide medical care for trial subjects, randomization procedures and unblinding, safety reporting, source data/document, case report forms, product management, premature termination or suspension of a trial, progress and final reports, and investigator’s files.