r4subtrace: Traceability Engine for Clinical Submission Readiness

2026 Dataset Open access

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Authors: Pawan Rama Mali
DOI: 10.32614/cran.package.r4subtrace
Cited by: 0

Abstract

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'.

Fields of Study & Subjects

Scientific Computing and Data Management Research Data Management Practices Statistical Methods in Clinical Trials

Publication details

Publication date
3 March 2026
Language
EN
Document type
Dataset