CRLN-TRG-001 — CRLN Clinical Research Competency Framework (Version 1.1)

CRLN-TRG-001 is an open competency framework for the global clinical-research workforce. It makes clinical-research competency measurable, comparable and portable across countries, languages and roles, anchored to ICH E6(R3) Good Clinical Practice and crosswalked to the Joint Task Force (JTF) Clinical Trial Competency Framework.

Contents: ten canonical competency domains (D-01…D-10); eight role tracks — Clinical Research Coordinator, Clinical Research Associate, Clinical Trial Administrator, Clinical Data Manager, Clinical Trial / Project Manager, Regulatory Affairs Specialist, Pharmacovigilance / Drug Safety Associate, and Principal Investigator — comprising 48 competency statements; a four-level performance scale with an explicit safety rule; composite and readiness-index scoring rules; and a standards crosswalk. The machine-readable specification (crln-trg-001.json), the change log and an adoption guide are included alongside the document.

Release 1.1.3 (2026-09-01) corrects the regulatory citations. ICH E6(R3) Annex 1 renumbered the guideline — R2 placed the Investigator at §4, the Sponsor at §5 and Essential Documents at §8, where R3 places them at §2, §3 and Appendix C — and 38 of the 48 competency domains cited the old section numbers under an "ICH E6(R3)" label. The mappings were correct; the addresses were not. All citations now use verified R3 Annex 1 anchors taken from the adopted guideline, and every non-ICH reference (21 CFR, GCDMP, CDISC, ALCOA+, ICH E2A, TransCelerate, the Declaration of Helsinki) is preserved unchanged. The competencies, scale, weights and scoring are untouched. The publisher is now named as Clinical Research Learning Network LLC, the registered entity. The competency content is exactly as published on 2026-08-21. It corrects two figures that were wrong in the 1.1 document, brings the machine-readable specification and the assessment engine into agreement with it, and adds the companion artifacts the standard's governance section promised.

The 1.1 document stated the framework comprised "56 competency statements … and 3 tracked framework versions". Both numbers came from counting the methodology registry without filtering, so both included the eight JTF v3.1 reference statements that CRLN-TRG-001 is crosswalked to rather than composed of. The correct figures are 48 statements across 2 published versions. Because a Zenodo record is immutable, the corrected paragraph and a visible note of what it previously said are published here as a new version rather than as a silent edit.

Normative note added in this release: domain codes D1–D6 are positional within a role. A Clinical Research Associate's D1 and a Clinical Data Manager's D1 are different competencies. Comparisons must use the fully-qualified identifier (CRLN-<ROLE>-<Dn>), never the bare code; aggregating on the bare code silently averages unrelated competencies and produces a result that is well-formed, in range, and wrong.

Status and stated limitations. The framework is published-provisional. The standards crosswalk (CRLN-TRG-001 ↔ JTF ↔ ICH E6(R3)) is undergoing subject-matter-expert review and remains provisional: 0 of 31 items have been independently attested. Of 200 jurisdictions covered, 39 are verified against primary sources; the remaining 161 record an inference that the jurisdiction relies on ICH E6(R3) as its GCP baseline and are likewise provisional.

Licensing. The framework and the standards crosswalk are licensed CC BY 4.0. The CRLN Readiness Index measurement engine, item parameters, calibrations and underlying data are proprietary and are not licensed hereunder; see the included adoption guide.