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S2O - A software tool for integrating research data from general purpose statistic software into electronic data

Philipp Bruland1, Martin Dugas2

  • 1Institute of Medical Informatics, University of Münster, 48149, Münster, Germany. philipp.bruland@uni-muenster.de.

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Summary
This summary is machine-generated.

Migrating clinical trial data from IBM SPSS to CDISC ODM is now feasible with a new converter. This facilitates secure, auditable data collection in Electronic Data Capture systems, meeting regulatory requirements.

Keywords:
Biomedical researchClinical trialsData managementDatabaseDatabase management systemsMetadataModel transformationSoftware toolsStatistical data

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Area of Science:

  • Clinical Informatics
  • Data Management
  • Regulatory Compliance

Background:

  • Clinical trial data capture often relies on spreadsheet applications like IBM SPSS, which lack robust security, role management, and audit trails.
  • These limitations prevent spreadsheet-based systems from meeting regulatory requirements for electronic data capture (EDC) in clinical trials.
  • Electronic Data Capture (EDC) systems offer secure, auditable data collection and typically support the CDISC ODM standard.

Purpose of the Study:

  • To develop a mapping model and implement a converter between IBM SPSS and the CDISC ODM standard.
  • To evaluate the syntactic and semantic correctness of the developed mapping and conversion process.

Main Methods:

  • A mapping model was developed to translate IBM SPSS variables and patient values into the CDISC ODM format.
  • The S2O (SPSS to ODM) converter was implemented as a command-line tool utilizing an SPSS internal Java plugin.
  • Validation involved checking syntactic and semantic correctness using various ODM tools and performing reverse transformations from ODM to SPSS.

Main Results:

  • The developed mapping model successfully translated SPSS variables and patient values into the CDISC ODM structure.
  • The S2O converter demonstrated the feasibility of transforming clinical data values into the ODM format.
  • While statistical and display attributes from SPSS did not directly map to ODM elements, the core data transformation was successful.

Conclusions:

  • The transformation between IBM SPSS and the CDISC ODM standard is feasible, enabling easier data migration.
  • The S2O converter facilitates the transition from spreadsheet-based data collection (Excel, SPSS) to more reliable EDC systems.
  • Adopting EDC systems through this migration allows for secure, traceable data collection and regulatory compliance.