Assessing the Integrity and Trustworthiness of Clinical Trials Data
Overview
The integrity package implements the IPD Integrity Tool, a structured and transparent framework for evaluating the integrity of individual participant data (IPD) from randomised trials (see Hunter et al. (2024) doi:10.1002/jrsm.1738 and doi:10.1002/jrsm.1739). It supports users to identify potential issues, such as unusual data patterns, implausible values, lack of expected correlations, date violations, and inconsistencies. The package provides reproducible workflows for screening, documenting and summarising integrity concerns, and may be applied by evidence synthesists, editors, and others to determine whether a randomised trial may be considered sufficiently trustworthy to contribute to the evidence base that informs policy and practice.
- Changed item 2.1 to a two-sided Wald-Wolfowitz runs test, aligning it with the published IPD Integrity Tool. Small or unbalanced category counts use exact conditional p-values; larger counts use a normal approximation.
- Item 2.1 detailed output now reports observed and expected runs, missing counts, p-values, and test methods instead of adjacent-pair counts. This changes the columns in
detail_tables[["2.1"]]. - Item 2.1 now sorts by the nominated randomisation date, retaining row order for ties. It warns and falls back to row order if no usable dates are available. Partly missing dates are excluded from this item with a warning.
- Clarified omission of missing baseline values and interpretation of untestable variables for item 2.1; recorded the ordering and date exclusions in the detailed output.
From NEWS.md in the release
Install
Health
- OK13 OK2026-08-05
- NOTE12 OK, 1 NOTE2026-08-01
- OK13 OK2026-06-09
- ERROR12 OK, 1 ERROR2026-06-08
- OK6 OK2026-04-09
Documentation
- Help pages
- 10
- Examples that run
- 100%10 run in a plain check (3 of them under a condition)
- Exported functions with examples
- 100%
- Documented parameters
- 100%
- Return-value docs
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- Help pages citing references
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Code & Tests
People & History
Previously maintained by Dario Strbenac (1.0).
Pick two releases to compare their code metrics.
- 1.0.3Latest2026-10-20 · current release · diff ↗ ·
6 hours in CRAN's queue
Listed in CRAN's incoming queue from 2026-10-20 06:56 to 2026-10-20 12:27 UTC, in 2 readings. - 1.0.22026-10-19 · diff ↗ ·
listed once in CRAN's queue
Seen in one reading of CRAN's incoming queue, at 2026-10-19 05:32 UTC, so it stayed less than the time between readings. - 1.0.1
- RR 4.6.0 released · 2026-04-24
- 1.02026-04-08
- RR 4.5.0 released · 2025-04-11
Package metadata
- First published
- 2026-04-08
- Total releases
- 4 / 1 yrs
- License
- GPL-3 OSI
- Minimum R
- ≥ 4.1.0
- Download size
- 393 KB
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