Clinical Visual Analytics for Review and Submission

Clinical Visual Analytics for Review and Submission

Purpose

Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submission for regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse event 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 FDA.

Dependencies

The latest version of the package works with the latest versions of the packages stated in DESCRIPTION.

If a previous version of the package should be used, it is recommended to use latest version of the dependencies at the point of time when the previous version of {cvars} was released.

Scope

• Build a toolbox of re-usable functions and utilities to create Clinical Domain tables and figures.
• Clinical Domain datasets which are used to create tables and figures should follow CDISC standards.