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https://github.com/Merck/metalite

An R package to create metadata structure for ADaM data analysis and reporting
https://github.com/Merck/metalite

cdisc clinical-trials metadata r-package

Last synced: 8 days ago
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An R package to create metadata structure for ADaM data analysis and reporting

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# metalite

[![CRAN status](https://www.r-pkg.org/badges/version/metalite)](https://CRAN.R-project.org/package=metalite)
[![Codecov test coverage](https://codecov.io/gh/Merck/metalite/branch/main/graph/badge.svg)](https://app.codecov.io/gh/Merck/metalite?branch=main)
[![CRAN Downloads](https://cranlogs.r-pkg.org/badges/metalite)](https://CRAN.R-project.org/package=metalite)
[![R-CMD-check](https://github.com/Merck/metalite/actions/workflows/R-CMD-check.yaml/badge.svg)](https://github.com/Merck/metalite/actions/workflows/R-CMD-check.yaml)
[![status](https://tinyverse.netlify.app/badge/metalite)](https://cran.r-project.org/package=metalite)

Unified representation of metadata structure for
clinical analysis & reporting (A&R) by leveraging the
Analysis Data Model (ADaM) datasets.

## Installation

The easiest way to get metalite is to install from CRAN:

```r
install.packages("metalite")
```

Alternatively, to use a new feature or get a bug fix,
you can install the development version of metalite from GitHub:

```r
# install.packages("remotes")
remotes::install_github("Merck/metalite")
```

## Overview

The metalite framework is designed to:

- Standardize function input for analysis and reporting.
- Separate analysis logic from data source.
- Enable the use of pipes (`|>`).
- Reduce manual steps to develop and maintain documentation in clinical trial development.
- Ensure consistency between analysis specification, mock, and results.

## Use cases

The metalite package offers a foundation to simplify tool development
and create standard engineering workflows.
For example, metalite can be used to:

- Standardize input and output for A&R functions.
- Create analysis and reporting planning grid.
- Create mock table.
- Create and validate A&R results.
- Trace analysis records.

Note: metalite is a low-level R package
that needs to work with other R packages to complete the work.
The idea is illustrated in the diagram above.

## Design principles

We built metalite with the following principles:

- Automation: prefer a function call more than a checklist.
- Single-entry: enter in one place, sync to all deliveries.
- For example, enter data source one time for all AE analysis.
- End-to-end: cover all steps in software development lifecycle (SDLC) from define to delivery.