r4subtrace-package: r4subtrace: Traceability Engine for Clinical Submission...

r4subtrace-packageR Documentation

r4subtrace: Traceability Engine for Clinical Submission Readiness

Description

Quantifies and explains end-to-end traceability between clinical submission artifacts (ADaM (Analysis Data Model) outputs, derivations, SDTM (Study Data Tabulation Model) sources, specs, code). Builds trace models from metadata and mapping sheets, computes trace levels, and emits standardized R4SUB (R for Regulatory Submission) evidence table rows via 'r4subcore'.

Author(s)

Maintainer: Pawan Rama Mali prm@outlook.in [copyright holder]

See Also

Useful links:


r4subtrace documentation built on March 4, 2026, 1:07 a.m.