| 临床试验机构研究者标准操作规程 |
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| 引用本文： | 陈炯华,熊宁宁,邹建东,蒋萌,刘芳,符为民.临床试验机构研究者标准操作规程[J].金属学报,2004,9(8):954-957. |
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| 作者姓名： | 陈炯华 熊宁宁 邹建东 蒋萌 刘芳 符为民 |
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| 作者单位： | 南京中医药大学附属医院国家药品临床研究基地, 南京210029, 江苏 |
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| 基金项目： | 国家科学技术部“临床试验关键技术及平台研究”课题资助(№2002AA2Z341i) |
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| 摘 要： | 依据SFDA《药品临床试验管理规范》,ICH GCP,WHO GCP,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。
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| 关 键 词： | 临床试验机构 研究者 标准操作规程 源文件 病例报告表 |
| 收稿时间： | 2003-07-19 |
| 修稿时间： | 2004-04-28 |
Standard operating procedures for investigators in institution of clinical trial |
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| CHEN Jiong-Hua,XIONG Ning-Ning,ZHOU Jian-Dong,JIANG Meng,LIU Fang,FU Wei-min.Standard operating procedures for investigators in institution of clinical trial[J].Acta Metallurgica Sinica,2004,9(8):954-957. |
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| Authors: | CHEN Jiong-Hua XIONG Ning-Ning ZHOU Jian-Dong JIANG Meng LIU Fang FU Wei-min |
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| Affiliation: | National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, 210029, J iangsu, China |
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| Abstract: | 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’sfiles. |
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| Keywords: | institution of clinical trial investigator Standard Operating Procedures(SOP) source document case report forms |
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