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TrialDB: A web-based Clinical Study Data Management System
C A Brandt1, A M Deshpande, C Lu
1Yale University School of Medicine, New Haven, CT, USA.
AMIA ... Annual Symposium Proceedings. AMIA Symposium
|January 20, 2004
Summary
Clinical Study Data Management Systems (CSDMSs) require complex Entity-Attribute-Value (EAV) modeling. Open-source software offers a valuable solution for developing these challenging EAV databases efficiently.
Area of Science:
- Biomedical Informatics
- Clinical Data Management
- Software Engineering
Background:
- Clinical Study Data Management Systems (CSDMSs) centralize data for clinical studies.
- Commercial CSDMSs like Oracle Clinical, ClinTrial, and MetaTrial are widely used.
- These systems must handle diverse data types across various clinical domains and investigators.
Purpose of the Study:
- To highlight the challenges in developing Entity-Attribute-Value (EAV) databases for CSDMSs.
- To discuss the benefits of utilizing pre-existing software for EAV database development.
- To advocate for the advantages of open-source solutions in this domain.
Main Methods:
- Analysis of existing commercial CSDMS architectures.
- Examination of Entity-Attribute-Value (EAV) modeling as a data management approach.
- Discussion of the development requirements for EAV database applications.
Main Results:
- Entity-Attribute-Value (EAV) modeling is the preferred design for institution-wide CSDMSs handling diverse clinical data.
- Developing EAV databases from scratch requires significant generic metadata-driven code.
- Commercial CSDMSs predominantly use EAV designs.
Conclusions:
- The development of custom EAV databases for clinical data management is complex and resource-intensive.
- Availability of pre-existing software, particularly open-source solutions, can significantly streamline CSDMS development.
- Open-source software offers a valuable and efficient approach to building robust CSDMSs.
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