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Checks whether an evidence table meets the requirements specified by a regulatory submission profile: required indicators present, required asset types covered, and minimum indicator coverage met.

Usage

validate_against_profile(evidence, profile)

Arguments

evidence

A validated evidence data.frame conforming to the r4subcore evidence schema.

profile

A submission_profile object.

Value

A list of class "profile_validation" with elements:

  • is_compliant: logical; TRUE if all requirements are met

  • missing_indicators: character vector of missing required indicator IDs

  • missing_asset_types: character vector of missing required asset types

  • coverage: numeric; fraction of required indicators present (0-1)

  • coverage_met: logical; whether coverage meets the minimum threshold

  • details: tibble with per-requirement status

Examples

if (FALSE) { # \dontrun{
prof <- submission_profile("FDA", "NDA")
result <- validate_against_profile(evidence, prof)
result$is_compliant
result$missing_indicators
} # }