Speakers
Description
Medical Data Review (MDR) in clinical trials requires study teams to examine patient-level data across dozens of CRF domains — adverse events, labs, vitals, ECGs, and more. Traditionally, this relies mainly on static listings generated per study, requiring extensive setup and line-by-line inspection. We present an R framework, built on teal, that replaces this workflow with interactive, intelligent, and reusable review applications.
The first layer is a template system: over 30 pre-built teal modules covering common MDR domains and indications (AE listings, lab panels, Hy's Law plots, ECG graphs, RECIST, discontinuation summaries). A single function scaffolds a complete application for any study by composing modules and wiring them to the study's data files.
The second layer adds intelligence. Audit trail integration detects records changed since a cutoff date and highlights modified cells with their previous values. An automated verification layer cross-references data across domains: AE-Lab discrepancy detection flags adverse events lacking corresponding lab entries, severity grade escalations are color-coded for immediate visibility, and serious AE indicators, drug withdrawals, and suspect drug flags are surfaced automatically. This shifts review from exhaustive scanning to targeted, exception-driven investigation.
An embedded AI assistant, connected to the live Shiny session via the Model Context Protocol, enables reviewers to query data conversationally — "which subjects have grade 4 AEs without drug withdrawal" — with answers grounded in the actual filtered dataset.
The poster demonstrates the architecture, cross-study scalability, and early results on review time reduction. The framework is built in R using teal, reactable, arrow, and bslib.
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| Keywords: Please list up to 5 keywords to help us find the right session for your contribution. | teal, medical data review, clinical trials, AI, anomaly detection, Shiny, pharmaverse |
|---|---|
| Virtual Option | This submission is for onsite presentation only |
| Video Recording | Video sharing is fine |
| The author(s) agree(s) to take responsibility and be accountable for the contents of the submission and is/are authorized to present it. | Confirm |