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r4subtrace: Traceability Engine for Clinical Submission Readiness
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'.
Getting started
Browse package contents
Package details |
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| Author | Pawan Rama Mali [aut, cre, cph] |
| Maintainer | Pawan Rama Mali <prm@outlook.in> |
| License | MIT + file LICENSE |
| Version | 0.1.0 |
| URL | https://github.com/R4SUB/r4subtrace |
| Package repository | View on CRAN |
| Installation |
Install the latest version of this package by entering the following in R:
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