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Open Access 01-12-2016 | Methodology

Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data

Author: Martin Dugas

Published in: Trials | Issue 1/2016

Abstract

Background

Clinical trials use many case report forms (CRFs) per patient. Because of the astronomical number of potential CRFs, data element re-use at the design stage is attractive to foster compatibility of data from different trials. The objective of this work is to assess the technical feasibility of a CRF editor with connection to a public metadata registry (MDR) to support data element re-use.

Results

Based on the Medical Data Models portal, an ISO/IEC 11179-compliant MDR was implemented and connected to a web-based CRF editor. Three use cases were implemented: re-use at the form, item group and data element levels.

Conclusions

CRF design with data element re-use from a public MDR is feasible. A prototypic system is available. The main limitation of the system is the amount of available MDR content.

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Title: Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data
Author: Martin Dugas
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1691-8

ACC 2024 Congress

Springer Medicine

Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data

Abstract

Background

Results

Conclusions

ACC 2024 Congress

Springer Medicine

Abstract

Background

Results

Conclusions

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