Clinical Trial Data-Cut Change Detection and Impact Assessment
Overview
A transparent, rule-based framework for detecting changes between successive data cuts of clinical trial datasets, classifying those changes into clinically meaningful categories, tracing user-defined data lineage, and assessing which downstream analyses and outputs may be affected. The package is designed to complement existing low-level data frame comparison tools by adding clinical-trial-specific classification, lineage and impact-assessment layers on top of deterministic comparison. The rule-based classification is similar in spirit to the data validation infrastructure of van der Loo and de Jonge (2021) doi:10.18637/jss.v097.i10.
- Added an analysis/output registry:
td_output()andoutput_registry()declare analyses and outputs and their inputs, andadd_outputs(),add_edges()andremove_edges()graft, extend or override a lineage graph. - Added
lineage_from_metadata(), which derives a lineage graph from a \pkg{metacore} object (or equivalent metadata tables), with provenance and a review list for ambiguous or unparsed references.aliasesresolve tokens that would otherwise be ambiguous or unknown, andoverridesmerge an analysis/output registry into the generated graph. - Added a
"diffdf"comparison backend tocompare_cut(), which delegates value comparison to the \pkg{diffdf} package and translates its output into atdiffobject (schema comparison remains built in). - Added a case-study vignette using public
pharmaverseadamdata.
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as_register()now coerces key columns to character, fixing a failure when key columns were not character.- New records in visit-based datasets are classified as
new_visitrather thannew_assessment. - Added edge-case tests; package coverage now exceeds 90%.
- Bumped GitHub Actions and added Codecov configuration.
From NEWS.md in the release
Install
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- OK6 OK2026-09-28
Documentation
- Help pages
- 29 (4 internal)includes a package overview page
- Examples that run
- 100%7 run in a plain check
- Exported functions with examples
- 32%
- Documented parameters
- 88%
- Return-value docs
- 100%
- Help pages citing references
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Code & Tests
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People & History
- 0.2.0Latest2026-09-27 · current release
- RR 4.6.0 released · 2026-04-24
Package metadata
- First published
- 2026-09-27
- Total releases
- 1 / 1 yrs
- License
- MIT + file LICENSE OSI
- Minimum R
- ≥ 4.1
- Bundled data
- 6.8 KB / 5 files
- Download size
- 126 KB
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