| Turning Access into a web-enabled secure information system for clinical trials. | |
| | |
MedLine Citation:
|
PMID: 19625330 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Dongquan Chen; Wei-Bang Chen; Mayhue Soong; Seng-Jaw Soong; Helmuth F Orthner |
Publication Detail:
|
Type: Journal Article; Research Support, N.I.H., Extramural Date: 2009-07-22 |
Journal Detail:
|
Title: Clinical trials (London, England) Volume: 6 ISSN: 1740-7753 ISO Abbreviation: Clin Trials Publication Date: 2009 Aug |
Date Detail:
|
Created Date: 2009-08-11 Completed Date: 2010-09-29 Revised Date: 2011-09-26 |
Medline Journal Info:
|
Nlm Unique ID: 101197451 Medline TA: Clin Trials Country: England |
Other Details:
|
Languages: eng Pagination: 378-85 Citation Subset: IM |
Affiliation:
|
Division of Preventive Medicine, University of Alabama, Birmingham, AL, USA. dongquan@uab.edu |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Clinical Trials as Topic
/
methods* Computer Security* Computer Systems Confidentiality* Data Collection Databases, Factual Humans Internet* Privacy* Software* |
| Grant Support | |
ID/Acronym/Agency:
|
1UL1RR025777/RR/NCRR NIH HHS; CA-13 148/CA/NCI NIH HHS; P30 CA013148-33/CA/NCI NIH HHS; P30 CA013148-34/CA/NCI NIH HHS; UL1 RR025777-01/RR/NCRR NIH HHS |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Process maps in clinical trial quality assurance.
Next Document: Brain abnormalities in Sjogren syndrome with recurrent CNS manifestations: association with neuromye...