A simple versatile solution for collecting multidimensional clinical data based on the CakePHP web application framework

Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are specialized software solutions geared toward GCP-trials. They are however less suited for data management in small non-GCP re...

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Veröffentlicht in:Computer methods and programs in biomedicine Jg. 114; H. 1; S. 70 - 79
1. Verfasser: Biermann, Martin
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Kidlington Elsevier Ireland Ltd 01.04.2014
Elsevier
Schlagworte:
Applied sciences
Biological and medical sciences
CakePHP
Clinical Data Management System
Computer science; control theory; systems
Computer systems and distributed systems. User interface
Computerized management (medical records, files, hospital management)
Computerized, statistical medical data processing and models in biomedicine
Data Collection - methods
Database Management Systems
Exact sciences and technology
Internal Medicine
Internet
Investigator-initiated clinical research
Medical sciences
Other
PHP
Software
Software engineering
Tumors
Web application framework
PHP
Investigator-initiated clinical research
CakePHP
Web application framework
Clinical Data Management System
Software development
Covering problem
Electrostatic discharge
Biomedical data processing
Cancerology
User interface
Graphical interface
World wide web
Database
Clinical trial
Log file
Hospital
Database management system
Medical application
Data analysis
Statistical analysis
Breaking in
Probabilistic approach
Charged device model
Client server architecture
Coverage
Malignant tumor
Male genital system
Information browsing
Clinical management
Data models
Internet
Cancer
Data gathering
ISSN:0169-2607, 1872-7565, 1872-7565
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Zusammenfassung:Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are specialized software solutions geared toward GCP-trials. They are however less suited for data management in small non-GCP research projects. For use in researcher-initiated non-GCP studies, we developed a client–server database application based on the public domain CakePHP framework. The underlying MySQL database uses a simple data model based on only five data tables. The graphical user interface can be run in any web browser inside the hospital network. Data are validated upon entry. Data contained in external database systems can be imported interactively. Data are automatically anonymized on import, and the key lists identifying the subjects being logged to a restricted part of the database. Data analysis is performed by separate statistics and analysis software connecting to the database via a generic Open Database Connectivity (ODBC) interface. Since its first pilot implementation in 2011, the solution has been applied to seven different clinical research projects covering different clinical problems in different organ systems such as cancer of the thyroid and the prostate glands. This paper shows how the adoption of a generic web application framework is a feasible, flexible, low-cost, and user-friendly way of managing multidimensional research data in researcher-initiated non-GCP clinical projects.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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content type line 23
ISSN:0169-2607
1872-7565
1872-7565
DOI:10.1016/j.cmpb.2014.01.007