An electronic regulatory document management system for a clinical trial network

被引：6

作者：

Zhao, Wenle

Durkalski, Valerie ^{[1
]}

Pauls, Keith

Dillon, Catherine

Kim, Jaemyung

Kolk, Deneil ^{[2
]}

Silbergleit, Robert ^{[2
]}

Stevenson, Valerie ^{[2
]}

Palesch, Yuko

机构：

[1] Med Univ S Carolina, Div Biostat & Epidemiol, Dept Biostat Bioinformat & Epidemiol, Charleston, SC 29425 USA

[2] Univ Michigan Hlth Syst, Dept Emergency Med, Ann Arbor, MI USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2010年 / 31卷 / 01期

关键词：

Clinical Trials Management System (CTMS); Electronic data capture; Regulatory documents; Web-based systems; Clinical Trials Network;

D O I：

10.1016/j.cct.2009.09.005

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. (C) 2009 Elsevier Inc. All rights reserved.

引用

页码：27 / 33

页数：7

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