Package 'r4subprofile'

List Supported Regulatory Authorities

Description

Returns a summary of all supported regulatory authorities with their full names, countries, and number of available submission types.

Usage

list_authorities()

Value

A tibble with columns: authority, full_name, country, n_submission_types.

Examples

list_authorities()

---

List Submission Types for an Authority

Description

Returns the valid submission types for a given regulatory authority.

Usage

list_submission_types(authority)

Arguments

authority

Character. A supported authority name.

Value

A character vector of valid submission types.

Examples

list_submission_types("FDA")
list_submission_types("EMA")

---

Print Profile Validation Result

Description

Print Profile Validation Result

Usage

## S3 method for class 'profile_validation'
print(x, ...)

Arguments

x	A profile_validation object.
...	Ignored.

Value

Invisibly returns x. Called for its side effect of printing the compliance status, coverage percentage, and any missing indicators or asset types to the console.

---

Print Submission Profile

Description

Print Submission Profile

Usage

## S3 method for class 'submission_profile'
print(x, ...)

Arguments

x	A submission_profile object.
...	Ignored.

Value

Invisibly returns x. Called for its side effect of printing a summary of the submission profile (authority, submission type, pillar weights, ready band, required indicators, and minimum coverage) to the console.

---

Get Required Indicators for a Profile

Description

Returns the list of indicator IDs that are mandatory for the given submission profile.

Usage

profile_required_indicators(profile)

Arguments

profile

A submission_profile object.

Value

A character vector of required indicator_id values.

Examples

prof <- submission_profile("FDA", "NDA")
profile_required_indicators(prof)

prof_ind <- submission_profile("FDA", "IND")
profile_required_indicators(prof_ind)

---

Extract Risk Configuration from a Profile

Description

Returns a list with structure compatible with r4subrisk::risk_config_default(). Can be passed directly to risk assessment functions.

Usage

profile_risk_config(profile)

Arguments

profile

A submission_profile object.

Value

A list of class "risk_config" with rpn_bands, evidence_severity_to_probability, evidence_severity_to_impact, and default_detectability.

Examples

prof <- submission_profile("FDA", "NDA")
cfg <- profile_risk_config(prof)
cfg$rpn_bands

---

Extract SCI Configuration from a Profile

Description

Returns a list with structure compatible with r4subscore::sci_config_default(). Can be passed directly to compute_pillar_scores() or compute_sci().

Usage

profile_sci_config(profile)

Arguments

profile

A submission_profile object.

Value

A list of class "sci_config" with pillar_weights and bands.

Examples

prof <- submission_profile("FDA", "NDA")
cfg <- profile_sci_config(prof)
cfg$pillar_weights
cfg$bands

---

Summarize a Submission Profile

Description

Prints a formatted summary of a regulatory submission profile including authority details, pillar weights, decision bands, and requirements.

Usage

profile_summary(profile)

Arguments

profile

A submission_profile object.

Value

The profile object, invisibly.

Examples

prof <- submission_profile("FDA", "NDA")
profile_summary(prof)

---

Create a Submission Profile

Description

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$pillar_weights
prof$required_indicators

prof_ema <- submission_profile("EMA", "MAA", study_phase = "Phase3")
prof_ema$bands

---

Validate Evidence Against a Submission Profile

Description

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

## Not run: 
prof <- submission_profile("FDA", "NDA")
result <- validate_against_profile(evidence, prof)
result$is_compliant
result$missing_indicators

## End(Not run)

---