Create a Submission Profile — submission

Constructs a regulatory submission profile with authority-specific pillar weights, decision bands, required indicators, and risk configuration.

Usage

submission_profile(authority, submission_type, study_phase = NULL)

Arguments

authority: Character. Regulatory authority name (e.g., "FDA", "EMA"). See list_authorities() for all supported values.
submission_type: Character. Submission type for the authority (e.g., "NDA", "MAA"). See list_submission_types() for valid values.
study_phase: Character or NULL. Optional study phase (e.g., "Phase1", "Phase2", "Phase3", "Phase4"). Currently informational.

Value

A list of class "submission_profile" with elements: authority, full_name, country, submission_type, study_phase, pillar_weights, bands, required_indicators, required_asset_types, minimum_coverage, rpn_bands, default_detectability.

Examples

prof <- submission_profile("FDA", "NDA")
prof$pillar_weights
#>   quality     trace      risk usability 
#>      0.35      0.25      0.25      0.15 
prof$required_indicators
#>  [1] "Q-MISS-VAR"        "Q-TYPE-MISMATCH"   "Q-LABEL-LEN"      
#>  [4] "Q-DUP-RECORDS"     "Q-FORMAT-ERR"      "T-ORPHAN-VAR"     
#>  [7] "T-TRACE-LEVEL"     "T-AMBIGUOUS-MAP"   "T-DERIVATION-DOC" 
#> [10] "R-HIGH-RPN"        "R-OPEN-RISK"       "R-MITIGATION-GAP" 
#> [13] "U-DEFINE-COMPLETE" "U-REVIEWER-NOTE"   "U-LABEL-QUALITY"  

prof_ema <- submission_profile("EMA", "MAA", study_phase = "Phase3")
prof_ema$bands
#> $ready
#> [1]  85 100
#> 
#> $minor_gaps
#> [1] 70 84
#> 
#> $conditional
#> [1] 50 69
#> 
#> $high_risk
#> [1]  0 49
#>