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Master Thesis

Standardisation via CDISC : intérêt et limites pour la gestion de données et la réalisation d'analyses statistiques au sein de l'USMR

Abstract : Clinical Data Interchange Standards Consortium (CDISC) is a non-profit international consortium that has published a series of standards in order to harmonize the formats of data collection and exchange throughout a clinical research. The purpose of this work is to explore to what extent their application is possible within a structure such as the unit of methodological support to clinical and epidemiological research (USMR) and if their implementation is needed. The conclusion of these reflections is that it could be envisaged to implement the CDISC standards to USMR if resources were given to the team, but that their application is not necessary with the current practices of the unit. However standardization within the team is a necessity, and the quality management system enable to implement it. To ensure the continuity of USMR activities, especially data analysis, programming work has also been incorporated into this project. The developed program can convert tables in a vertical format to a horizontal format.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02402992
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Submitted on : Tuesday, December 10, 2019 - 4:58:54 PM
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Pauline Gaffez. Standardisation via CDISC : intérêt et limites pour la gestion de données et la réalisation d'analyses statistiques au sein de l'USMR. Santé publique et épidémiologie. 2019. ⟨dumas-02402992⟩

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