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r4subusability is the usability pillar package in the R4SUB ecosystem. It quantifies reviewer-experience indicators for clinical regulatory submissions, assessing variable label quality, Define-XML completeness, dataset annotation coverage, and reviewer guide presence.

Evidence rows follow the standard R4SUB schema from r4subcore, making them directly compatible with r4subscore (SCI scoring) and r4subprofile (authority-specific profiling).

Installation

install.packages("r4subusability")

Development version:

pak::pak(c("R4SUB/r4subcore", "R4SUB/r4subusability"))

Quick Start

library(r4subusability)

meta <- data.frame(
  dataset  = c("ADSL", "ADAE"),
  variable = c("USUBJID", "AETERM"),
  label    = c("Unique Subject Identifier", "Reported Term for the Adverse Event"),
  origin   = c("Assigned", "CRF"),
  type     = c("text", "text"),
  stringsAsFactors = FALSE
)

results <- usability_indicators(meta, study_id = "STUDY-001")
usability_summary(results)

Usability Indicators

Function Indicator Description
assess_label_quality() U-001 Variable label length and format
assess_define_completeness() U-002 Define-XML field completeness
assess_annotation_coverage() U-003 Dataset annotation coverage
assess_reviewer_guide() U-004 Reviewer guide presence

Key Functions

Function Purpose
usability_config_default() Default usability thresholds and configuration
usability_indicators() Run all four usability indicators in one call
assess_label_quality() Check variable label quality (U-001)
assess_define_completeness() Check Define-XML completeness (U-002)
assess_annotation_coverage() Check annotation coverage (U-003)
assess_reviewer_guide() Check reviewer guide presence (U-004)
usability_summary() Tidy summary of usability results

License

MIT