| 临床试验数据采集与报告文件设计制作的技术规程 |
| |
| 引用本文： | 王怡兵,熊宁宁,卜擎燕,邹建东,蒋萌,刘芳,符为民. 临床试验数据采集与报告文件设计制作的技术规程[J]. 中国临床药理学与治疗学, 2004, 9(5): 595-597 |
| |
| 作者姓名： | 王怡兵 熊宁宁 卜擎燕 邹建东 蒋萌 刘芳 符为民 |
| |
| 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 |
| |
| 基金项目： | 科技部“临床试验关键技术及平台研究”课题资助 (№ 2 0 0 2AA2Z3 41i) |
| |
| 摘 要： | 临床试验数据采集与报告文件的设计和制作对保证试验数据的质量与完整性至关重要。参照临床试验数据管理规范 (GCP)并结合具体实践经验制订本规程。设计规程包括与方案设计同步、文件格式、问题和提示、冗余数据、数据记录指南、标准化、版本管理与培训 ;印制规程包括审批、印制说明书以及厂商选择。
|
| 关 键 词： | 数据管理 数据采集 源文件 病例报告表 技术规程 |
| 文章编号： | 1009-2501(2004)05-0595-03 |
| 修稿时间： | 2003-12-02 |
Technical procedure for design and development of clinical trial data collecting and reporting documents |
| |
| WANG Yi-Bing,XIONG Ning-Ning,BO Qing-Yan,ZHOU Jian-Dong,JIANG Meng,LIU Fang,FU Wei-MinNational Base for Drug Clinical Trial,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing,,Jiangsu,China. Technical procedure for design and development of clinical trial data collecting and reporting documents[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2004, 9(5): 595-597 |
| |
| Authors: | WANG Yi-Bing XIONG Ning-Ning BO Qing-Yan ZHOU Jian-Dong JIANG Meng LIU Fang FU Wei-MinNational Base for Drug Clinical Trial Affiliated Hospital of Nanjing University of Traditional Chinese Medicine Nanjing Jiangsu China |
| |
| Affiliation: | WANG Yi-Bing,XIONG Ning-Ning,BO Qing-Yan,ZHOU Jian-Dong,JIANG Meng,LIU Fang,FU Wei-MinNational Base for Drug Clinical Trial,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing,210029,Jiangsu,China |
| |
| Abstract: | The quality and integrity of the clinical trial data rely importantly on the design and compilation of report documents and the collection of trial data. Therefore,based on practical experiences and with reference to the Good Clinical Data Management,we develop this technical procedure,including designing and printing procedures. |
| |
| Keywords: | data record data collecting source document case report form (CRF) technical procedure |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
