ADaM in R Asset Library - Ophthalmology

Aids the programming of Clinical Data Standards Interchange Consortium (CDISC) compliant Ophthalmology Analysis Data Model (ADaM) datasets in R. ADaM datasets are a mandatory part of any New Drug or Biologics License Application submitted to the United States Food and Drug Administration (FDA). Analysis derivations are implemented in accordance with the "Analysis Data Model Implementation Guide" (CDISC Analysis Data Model Team, 2021, < https://www.cdisc.org/standards/foundational/adam/adamig-v1-3-release-package>).

admiralophtha

Ophthalmology extension package for ADaM in R Asset Library {admiral}.

Explore all the other packages in the {admiral} ecosystem to learn more about ADaM programming in R.

Purpose

To provide a complementary (to {admiral}) toolbox that enables users to develop ophthalmology disease area datasets and endpoints.

Installation

To install the latest development version of the package directly from GitHub use the following code:

pak::pkg_install("admiralophtha", dependencies = TRUE)

Scope

• Build a toolbox of re-usable functions and utilities to create Ophthalmology-specific ADaM datasets in R in a modular manner.
• All functions are created based upon the ADaM Implementation Guide and aim to facilitate the programming of ADaM dataset standards.

References and Documentation

• Please refer to the {admiral} References and Documentation.

R Versions

Here's a summary of our strategy for this package related to R versions:

• R versions for developers and users will follow the same as {admiral} core package.
• For development the main branch of {admiral} core is used as a dependency. For releasing a new {admiralophtha} version it must run using the latest released {admiral} core version, i.e., also the main branch of {admiral} core.

Contact

We use the following for support and communications between user and developer community:

• Slack - for informal discussions, Q&A and building our user community. If you don't have access, use this link to join the pharmaverse Slack workspace
• GitHub Issues - for direct feedback, enhancement requests or raising bugs

Release Schedule

Acknowledgments

Along with the authors and contributors, thanks to the following people for their work on the package:

Ritika Aggarwal, Jane Gao, William Holmes, Josie Jackson, Sonali Jain, Rachel Linacre, Gordon Miller, Lucy Palmen, Aldrich Salva, Nandini R Thampi, Steven Ting.