pharmaverseadamjnj

Generate ADaM datasets aligned with Johnson & Johnson’s Clinical and Statistical Programming standards.

Features

• Generates ADaM datasets that comply with J&J standards
• Built on top of the pharmaverseadam package
• Implements data conversion from pharmaverse format to J&J standards format
• Provides reproducible and consistent test data

Implemented Datasets

Currently supports the following ADaM domains:

• ADSL (Subject Level Analysis Dataset)
• ADAE (Adverse Events Analysis Dataset)
• ADCM (Concomitant Medications Analysis Dataset)
• ADEG (ECG Analysis Dataset)
• ADEX (Exposure Analysis Dataset)
• ADESUM (Exposure Analysis Summary Dataset)
• ADLB (Laboratory Test Results Analysis Dataset)
• ADVS (Vital Signs Analysis Dataset)
• ADTTESAF (Time-to-Event Safety Analysis Dataset)
• ADAEFMQ (Adverse Events Analysis Dataset FDA Medical Query)

Installation

You can install the development version from GitHub:

# install.packages("devtools")
devtools::install_github("johnsonandjohnson/pharmaverseadamjnj")

Usage

library(pharmaverseadamjnj)

# Access the ADaM datasets directly
# These datasets are loaded lazily when the package is loaded
head(adsl)
head(adae)
head(adlb)
# ... and similarly for other domains

Data Sources

Test datasets have been sourced from the pharmaverseadam package, which utilized the data from the pharmaversesdtm package and the CDISC pilot project.