INSIGHT Quality Checks
Semantic harmonisation
Before a VAC4EU RWE study can be conducted, the DEAPs need to ensure the RWD source is well-suited to answer the research question, via Quality Checks (QC). The QC process is supported through INSIGHT, an open-source tool developed specifically for the ConcePTION CDM and since adapted for use by the VAC4EU study network. The tool consists of a series of R scripts, which DEAPs run locally, then upload to a secure research environment for centralised assessment. The scripts are publicly available on the UMC Utrecht GitHub.
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INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine SafetyHoxhaj V, Andaur Navarro CL, Riera-Arnau J, et al (2025)