Framework, Reference material
CRLN-TRG-001: CRLN Clinical Research Competency Framework (Version 1.7.4)
CRLN-TRG-001 is an open competency framework for clinical research site roles. It defines fourteen role tracks, from Clinical Research Coordinator to Laboratory Technician, each scored on role-specific domains grouped under ten canonical domains. Each domain is anchored to a clause of ICH E6(R3) Good Clinical Practice, and a four-level rubric says what each level of performance looks like.
Educators can use it to build learning outcomes, assessments and reading lists for clinical research courses and site training programs. Employers and sites can use it to write role descriptions and training plans. It is published on Zenodo under CC BY 4.0 with a permanent DOI, and anyone may reuse, adapt and redistribute it with attribution, including organizations that compete with CRLN.
Status and limits: the mapping from the ten canonical domains to ICH E6(R3) and the Joint Task Force competency framework has been reviewed, and the finer mappings and jurisdiction crosswalks have not been reviewed. CRLN-TRG-001 is published by CRLN and is not issued by any outside standards body.
Maintained by the Clinical Research Learning Network. Learners and sites never pay to use CRLN's practice scenarios.
DOI: https://doi.org/10.5281/zenodo.22049549
Licence: Creative Commons Attribution 4.0 International
Contact: Joshua Webber, Clinical Research Learning Network (CRLN), [email protected]
Keywords: clinical research, clinical trials, competency framework, ICH E6(R3), Good Clinical Practice, GCP, site staff, clinical research coordinator, workforce development, open educational resource
Competency level: •• Intermediate
Target audience: Clinical research professionals, Educators and trainers, Research site training leads
Resource type: Framework, Reference material
Version: 1.7.4
Status: Active
Learning objectives:
- Describe the competencies expected of each clinical research site role, from coordinator to laboratory technician.
- Relate each competency domain to the ICH E6(R3) Good Clinical Practice clause it is anchored to.
- Use the four-level rubric to plan training and assessment for site staff.
Date published: 2026-09-29
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