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Contemp Clin Trials. 2010 Jan;31(1):27-33. doi: 10.1016/j.cct.2009.09.005. Epub 2009 Sep 24.

An electronic regulatory document management system for a clinical trial network.

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Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA.


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.

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