r-r4subdata 0.1.1
Propagated dependencies: r-tibble@3.3.0
Channel: guix-cran
Home page: https://github.com/R4SUB/r4subdata
Licenses: Expat
Build system: r
Synopsis: Example Datasets for Clinical Submission Readiness
Description:
This package provides realistic synthetic example datasets for the R4SUB (R for Regulatory Submission) ecosystem. Includes a pharma study evidence table, ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model) metadata following CDISC (Clinical Data Interchange Standards Consortium) conventions (<https://www.cdisc.org>), traceability mappings, a risk register based on ICH (International Council for Harmonisation) Q9 quality risk management principles (<https://www.ich.org/page/quality-guidelines>), and regulatory indicator definitions. Designed for demos, vignettes, and package testing.
Total results: 1