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A Concept for a Data Dictionary System Supporting for Clinical Research.

Moritz Strickler1, Chantal Zbinden1, Ramon Saccilotto2

  • 1Bern University of Applied Sciences, Biel, Switzerland.

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Summary

Developing a standardized data dictionary system simplifies clinical trial data collection. This web application facilitates the creation and sharing of case report form (CRF) definitions, improving efficiency and data exchange in medical research.

Keywords:
Case Report FormCase Report Form DesignClinical ResearchData DictionaryElectronic Data Capture SystemMetadataStandard Templates

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Area of Science:

  • Clinical Trials
  • Medical Informatics
  • Data Management

Background:

  • Clinical trials are essential for evidence-based medicine, comparing interventions and devices.
  • Current case report form (CRF) preparation is complex, time-consuming, and lacks global standardization.
  • Inconsistent CRF design hinders data definition exchange between research groups.

Purpose of the Study:

  • To develop a freely accessible web application portal for creating and managing CRF, variable, and table definitions.
  • To establish a data dictionary system for use throughout the study workflow.
  • To enable the sharing and reuse of metadata, improving data consistency and interoperability.

Main Methods:

  • Conceptualized a web application for defining CRFs, variables, and tables.
  • Designed the system to allow export of data definitions for integration with electronic data capture (EDC) systems.
  • Focused on creating a reusable metadata framework.

Main Results:

  • A concept for a web-based portal to create and manage data definitions was developed.
  • The system allows for the export of definitions to EDC systems for CRF generation.
  • The proposed data dictionary system aims to streamline the entire study workflow.

Conclusions:

  • The developed concept addresses challenges in CRF design and data management.
  • A standardized data dictionary system can improve efficiency and data sharing in clinical research.
  • The portal facilitates the creation and reuse of metadata, supporting evidence-based medicine.