validate_submission: Validate a study-data folder

In openstudyval: Open Validator for FDA Study-Data Submissions

Validate a study-data folder

Description

Reads datasets, then runs XPORT constraints, standard-specific structural checks, the built-in rule catalog, technical-rejection criteria, and an optional define.xml cross-check.

Usage

validate_submission(
  path,
  standard = c("SDTM", "SEND", "ADaM"),
  define = NULL,
  rules = NULL,
  ct = NULL,
  version_label = "openstudyval 0.1.0"
)

Arguments

path	Directory of datasets, or a vector of dataset files.
standard	One of "SDTM", "SEND", or "ADaM".
define	Optional path to define.xml. If NULL, a file named define.xml in path is used when present.
rules	Optional data frame of extra rules. See add_custom_rules.
ct	Optional data frame of controlled terminology. Column names are variable names and values are permitted terms.
version_label	Character label stored on the report.

Details

The result is not a regulatory certification. Agency engines remain the reference for a live submission.

Value

An object of class osv_report.

See Also

validate_datasets, write_validation_report

Examples

report <- validate_submission(example_study("sdtm"), standard = "SDTM")
summary(report)

openstudyval documentation built on Oct. 21, 2026, 5:14 p.m.