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Description

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>).

Admiral Extension for Ophthalmology

TestCoverage

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:

if (!requireNamespace("remotes", quietly = TRUE)) {
  install.packages("remotes")
}
remotes::install_github("pharmaverse/admiralophtha", ref = "devel")

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

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 devel 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., 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

  • The first release (v. 0.1.0) came out on 13th March 2023.
  • The second release (v. 0.2.0) came out on 12th June 2023.
  • The third release (v. 0.3.0) came out on 18th September 2023.
  • We are planning for a fourth release (v.1.0) on December 11th 2023. The objective of the 1.0 release of {admiralophtha} is to provide a package that is mature enough to be used as it is as part of the ADaM work on any ophthalmology study.
Metadata

Version

1.0.0

License

Unknown

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