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StatsTFLValR


Overview

StatsTFLValR is an R package providing reusable, audit-ready utilities for validation of clinical trial datasets and outputs.
It is designed to support dataset review, comparison, counting, and table-level verification commonly required in regulated statistical programming workflows.

The package emphasizes:

  • Standardization and reproducibility
  • Transparent validation logic
  • Clear, review-friendly outputs
  • Integration with controlled and GxP-aligned programming environments

StatsTFLValR is intended for use by Statistical Programmers, Statisticians, and validation reviewers.


Key Features

Scope and Capabilities

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Install

install.packages('StatsTFLValR')

Version

1.0.0

License

MIT + file LICENSE

Issues

Pull Requests

Stars

Forks

Maintainer

Mangesh Kalsekar

Last Published

January 29th, 2026

Functions in StatsTFLValR (1.0.0)

get_column_info

Extract Column Metadata from a Data Frame
generate_compare_report

Compare DEV vs VAL datasets (PROC COMPARE-style) with robust file detection
get_data

Load Data Files of Various Formats
SOCbyPT

SOC → PT summary by treatment (wide), with optional BY-grouping, SOC totals, UNCODED positioning, BY-specific Big-N, and optional Big-N printing
freq_by_line

One-Line Frequency Summary by Treatment Group
SOCbyPT_Grade

SOC → PT summary by treatment with Grade split (wide)
sas_round

SAS-Compatible Rounding
ATCbyDrug

Fully Nested ATC2 → ATC4 → Drug (CMDECOD) Table by Treatment (wide)
mean_by

Summary Table: Mean and Related Statistics by Group
freq_by

Frequency Table by Group (wide): n (%) with flexible ordering and formats