r4subdata: Example Datasets for Clinical Submission Readiness
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.
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