Trust Center
Assessment Standards
Every Competency Passport is built on a standardized rubric. This document describes how our assessments are designed, which competencies they measure, and how scores are produced.
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. Framework alignment is a design principle, not an endorsement: Competency Labs is independent and not accredited by these bodies unless expressly stated.
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 GCP training required by your employer or sponsor.
Maintained by Competency Labs. Contact support@competencylabs.com for corrections or questions.
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