Research

Assessment Framework

The Competency Passport is built on a standardized framework that maps role-specific tasks to observable, measurable competencies. This document describes the domains, the rubric, and how scores are produced.

Last updated July 2026

Framework alignment

Our rubrics are informed by widely recognized clinical research competency frameworks, including the Joint Task Force for Clinical Trial Competency, ICH-GCP principles, and global regulatory expectations for site staff. Alignment is a design principle, not an endorsement: Competency Labs is independent and not accredited by these bodies unless expressly stated.

Core competency domains

Each role assessment measures competency across four categories:

Scientific & protocolProtocol comprehension, eligibility, informed consent, and study design judgment.
Regulatory & ethicalICH-GCP application, IRB/IEC obligations, and reporting of deviations and safety events.
Operational executionSource documentation, data quality, monitoring readiness, and query resolution.
Communication & judgmentSponsor, site, and participant communication under realistic constraints.

Two-layer scoring model

Assessments are scored on two independent layers: competency (did the response demonstrate the underlying skill) and entrustability (would a supervisor allow this person to perform this task with the observed level of supervision). Both layers appear on the Passport.

What a score is — and is not

A CompetencyScore™ is a standardized measurement of applied judgment on evidence-based scenarios. It is not a course grade, a certification, a job guarantee, or a substitute for employer- or sponsor-required training.

Versioning and auditability

Rubric versions, scoring models, and reviewer decisions are recorded for every verified result. A Passport issued today will always reference the framework version that was current at the time of assessment. Historical scores are never retroactively changed.

Competency Labs is not affiliated with, endorsed by, or accredited by any framework body or regulatory authority unless expressly stated in a formal written notice.

Maintained by the Competency Labs research team. Contact support@competencylabs.com for corrections, citations, or collaboration.