profile_sci_config

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

Defines submission profiles per regulatory authority with
authority-specific pillar weights, decision thresholds, indicator
requirements, and risk configuration. Supports the U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and
Medical Devices Agency (PMDA), Health Canada, Therapeutic Goods
Administration (TGA), and Medicines and Healthcare products Regulatory
Agency (MHRA). Integrates with 'r4subscore' and 'r4subrisk' configuration
systems.

Pawan Rama Mali

r4subprofile

Regulatory Submission Profiles for Clinical Submission Readiness

profile_sci_config function

<dl><dt>profile</dt>
<dd>A <code>submission_profile</code> object.</dd></dl>

Arguments

Extract SCI Configuration from a Profile — profile_sci_config

<dl>

<dt>profile</dt>
<dd>A <code>submission_profile</code> object.</dd>

</dl>

profile_sci_config: Extract SCI Configuration from a Profile

Description

Usage

Value

Arguments

Examples