|
|||||
|
|
| 药物临床试验安全性报告的规范 | |
| 引用本文： | 邢建民,李迅,刘建平. 药物临床试验安全性报告的规范[J]. 中国药物警戒, 2010, 7(4): 202-205 |
| 作者姓名： | 邢建民 李迅 刘建平 |
| 作者单位： | 北京中医药大学循证医学中心,北京,100029 |
| 基金项目： | 国家重点基础研究发展计划(973计划)，科技部国际合作项目 |
| 摘 要： | 从药物临床试验的定义及各分期对安全性的要求强调安全性报告的重要性。简单介绍药物临床试验安全性报告的现状,并对CONSORT声明扩展版中针对药物有害性临床试验报告的标准及条目进行解释。 |
| 关 键 词： | 安全性 不良事件 临床试验 Consort声明 中药 |
A Proposal for Safety Reporting of Drug Randomized Controlled Trials |
|
| XING Jian-min,LI Xun,LIU Jian-ping. A Proposal for Safety Reporting of Drug Randomized Controlled Trials[J]. Chinese JOurnal of Pharmacovigilance, 2010, 7(4): 202-205 | |
| Authors: | XING Jian-min LI Xun LIU Jian-ping |
| Affiliation: | (Center for Evidence-based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China) |
| Abstract: | To introduce the importance of safety reporting in clinical trials from the aspect of drug clinical trial＇s definition and classification of different stages,briefly summarize the current situation of safety reporting in drug clinical trials,and explain the reporting standards of drug clinical trials based on the recommendations of Consort extension on harm. |
| Keywords: | safety adverse event clinical trial Consort statement Chinese Traditional Medicine |
| 本文献已被 维普 万方数据 等数据库收录！ | |