From Informed Consent through Database Lock: An Interactive Clinical Trial Conducted Using the Internet

被引:0
作者
Kristin L. Eilenberg
Amy M. Hoover
Michael L. Rutherford
Catherine A. Melfi
Scott Segal
机构
[1] Eli Lilly and Company,Lilly Corporate Center
[2] Indiana University,Department of Medicine
来源
Drug information journal : DIJ / Drug Information Association | 2004年 / 38卷 / 3期
关键词
Online; World Wide Web; Internet; Clinical research design; Tadalafil;
D O I
暂无
中图分类号
学科分类号
摘要
This paper describes an interactive clinical trial that utilized the World Wide Web and Internet technologies throughout the conduct of the trial from informed consent through database lock and study closure. We believe this is the first development and administration of an interactive clinical trial that utilized the Internet for trial execution while complying with regulations for clinical trials conducted under an Investigational New Drug application.
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页码:239 / 251
页数:12
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