| 电子数据捕获系统在新药临床试验中的影响 |
| |
| 引用本文： | 冷文玉,蒋志伟,于莉莉,李婵娟. 电子数据捕获系统在新药临床试验中的影响[J]. 金属学报, 2013, 18(2): 217-221 |
| |
| 作者姓名： | 冷文玉 蒋志伟 于莉莉 李婵娟 |
| |
| 作者单位： | 1.济南军区总医院信息科,济南 250031,山东;2.第四军医大学卫生统计学教研室,西安 710032,陕西 |
| |
| 基金项目： | 国家自然科学基金项目(81072390; 81001290) |
| |
| 摘 要： | 随着计算机和网络技术的发展,电子数据捕获(EDC)系统在新药临床试验中的优势不断显现,并受到新药临床试验研究机构的青睐。EDC凭借其技术上的优势,简化了传统以纸张病例报告表为载体的临床试验流程,克服了其数据录入和数据清理滞后的缺点;研究者、临床监查员、数据管理人员等在应用EDC系统情况下的角色和职责分工也发生了相应的改变;同时,其为新的试验设计和统计方法,如适应性设计方法的应用实施提供的有利的平台。
|
| 关 键 词： | 电子数据捕获 病例报告表 源数据核对 适应性设计 |
| 收稿时间： | 2012-05-20 |
| 修稿时间： | 2012-05-20 |
Effect of electronic data capture system in new drug clinical trials |
| |
| LENG Wen-yu,JIANG Zhi-wei,YU Li-li,LI Chan-juan. Effect of electronic data capture system in new drug clinical trials[J]. Acta Metallurgica Sinica, 2013, 18(2): 217-221 |
| |
| Authors: | LENG Wen-yu JIANG Zhi-wei YU Li-li LI Chan-juan |
| |
| Affiliation: | 1.Department of Information, Jinan General Hospital, Jinan 250031, Shandong,China;2.Department of Health Statistics, Fourth Military Medical University, Xi'an 710032, Shaanxi,China |
| |
| Abstract: | With the developments of computer and net technology, the superiorities of Electronic Data Capture(EDC) system are increasing in clinical trials and it is getting popularity in trial participants. With the help of the excellent technologies, EDC simplifies the trial process of traditional paper CRFs and overcomes the lags of data entry and data cleaning. The roles and responsibilities of sponsors, monitors and data managers change. Meanwhile, EDC makes it feasible to apply new trial designs and statistical methods, such as, adaptive design. |
| |
| Keywords: | Electronic data capture Case report form Source document verification Adaptive design |
|
| 点击此处可从《金属学报》浏览原始摘要信息 |
|
点击此处可从《金属学报》下载全文 |
|
