Electronic Clinical Trial (eCT) Management System Development

Motivation:

Contemporary Clinical Trial Management Systems lack an intermediate layer for
Electronic Case Report Form (eCRF) representation and Common Data Element (CDE)
and Common eCRF Section implementation, and the tight connection between clinical data entry interface
and data management architecture disables non-IT oriented user to take full capacity of the system.

Purpose:

  • To provide clinical trial community with environment where sharing of CDE, Common eCRF Section, and clinical trial outcome are possible.
  • To enable remote clinical trial entry through remote entry with frontend validation possible.
  • To provide non-IT oriented users with easy-to-use clinical trial mangement system.

    • Method:

    Fund:

  • National Research Laboratory (NRL) Project: 2003.6 ~ 2005.5
  • Funded by the Ministry of Science and Technology

    • Clinical Trial Process Management System Development:

  • XML and Internet based Clinical Trial Process Management System
  • PhactaDesigner: eCRF Design Program (2004.7 ~ 2004.10)
  • PhactaElements: Common Data Element (CDE) Management Website (2004.9 ~ 2004.12)
  • PhactaManager: Clinical Trial Process Management System (2004.9 ~ 2005.2)
  • PhactaRetriever: Clinical Trial Data Retrival for Statistical Analysis (2005.1 ~ 2005.2)

    • PhactaDesigner:

  • eCRF 3.0 Grammar Design (done)
  • eCRF 3.0 Validation (done)
  • XML to HTML Transformation (done)
  • Communication with PhactaElements for CDE Transfer

    • PhactaElements:

  • CDE Registry and Management
  • CDE in five fields (Antiobiotics, Psychotripics, Antihypertension, Anticancer, NSAIDs)

    • PhactaManager:

  • Clinical Data in Relational Database Modeling

    • Publications:

    Related Journal Papers:

    Related Standards:

  • International Conference on Harmonization (ICH)
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Health Level 7 (HL7)