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


OBJECTIVE
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.


CONCLUSIONS
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.
Dongquan Chen
Division of Preventive Medicine, University of Alabama, Birmingham, AL, USA. dongquan@uab.edu
Chen
Wei-Bang
WB
Soong
Mayhue
M
Soong
Seng-Jaw
SJ
Orthner
Helmuth F
HF
D002986:Clinical Trials as Topic / Q000379:methods*; D016494:Computer Security; D003199:Computer Systems; D003219:Confidentiality; D003625:Data Collection; D016208:Databases, Factual; D006801:Humans; D020407:Internet; D018907:Privacy; D012984:Software