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carver

Clinical Analysis Reporting and Visualization Ensemble in R

Purpose

To develop an open-source tool and package to enable generation of common analysis reports (tables and interactive plots) for clinical review and direct inclusion in submission for regulatory agencies. This includes a Shiny application for complete safety report generation from Analysis Model (ADaM) datasets.

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 {carver} was released.

Installation

You can install the development version of this package from GitHub by running:

# install.packages("devtools")
devtools::install_github("pfizer-opensource/carver")

Scope

While {carver} aims to target several commonly used reports, it will not cover all reports needed for a submission. Through collaboration across the industry we might achieve greater coverage, but it might never be exhaustive. We encourage users to leverage these utilities to build their own specific reports additionally.

  • 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.
  • Inclusion of relevant patient-level (patient profile) figures, accessible from overall results.