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. 2009 Aug;6(4):378-85.
doi: 10.1177/1740774509338228. Epub 2009 Jul 22.

Turning Access into a web-enabled secure information system for clinical trials

Dongquan Chen  1 , Wei-Bang Chen, Mayhue Soong, Seng-Jaw Soong, Helmuth F Orthner
Affiliations

Turning Access into a web-enabled secure information system for clinical trials

Dongquan Chen et al. Clin Trials. 2009 Aug.

Abstract

Background: Organizations that have limited resources need to conduct clinical studies in a cost-effective, but secure way. Clinical data residing in various individual databases need to be easily accessed and secured. Although widely available, digital certification, encryption, and secure web server, have not been implemented as widely, partly due to a lack of understanding of needs and concerns over issues such as cost and difficulty in implementation.

Purpose: The objective of this study was to test the possibility of centralizing various databases and to demonstrate ways of offering an alternative to a large-scale comprehensive and costly commercial product, especially for simple phase I and II trials, with reasonable convenience and security.

Methods: We report a working procedure to transform and develop a standalone Access database into a secure Web-based secure information system.

Results: For data collection and reporting purposes, we centralized several individual databases; developed, and tested a web-based secure server using self-issued digital certificates.

Limitations: The system lacks audit trails. The cost of development and maintenance may hinder its wide application.

Conclusions: The clinical trial databases scattered in various departments of an institution could be centralized into a web-enabled secure information system. The limitations such as the lack of a calendar and audit trail can be partially addressed with additional programming. The centralized Web system may provide an alternative to a comprehensive clinical trial management system.

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Figures

Figure 1
Figure 1
Network architecture for a secure information system. The AD with a DNS controller enables clients/users to access the database through RAS and web interface
Figure 2
Figure 2
A web-enabled clinical trial database for data entry and reporting. The web-enabled system uses Access-derived forms over the web. Authorized users access data entry forms and reports over the web
Figure 3
Figure 3
The web-based data entry for protocols. The protocol registration form is one of many forms used to collect protocol-related information. The collected data was inserted into a table of the database through SQL query and active server pages
Figure 4
Figure 4
The query-based report gateway. The report section leads to both local and national reports that may require certain information in a fixed format. Mort reports are in read-only Portable Document Format (PDF) format
See this image and copyright information in PMC

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