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Project Scope:

Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submissions to regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is a collaboration among the American Statistical Association (ASA), PHUSE and the FDA.

Current Status:

• Updated CVARS version with E2E implementation and shinylive deployment.

• Final manuscript for CVARS E2E implementation.

Regular Project Meeting Day/Time:

Key Skills: (currently being reviewed by WG Leads)

• Experience in Open Source

• Experience in forest and volcano plots for adverse events and FDA Medical Queries (FMQs)

• Experience with R Shiny