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TrialDB: A web-based Clinical Study Data Management System.

C A Brandt1, A M Deshpande, C Lu

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Summary
This summary is machine-generated.

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.

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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.