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CRLN grades every decision against a published competency framework. That framework is not a product and it is not ours to withhold. It is CC BY 4.0, it has a DOI, and anyone may build on it, including organizations that compete with us.

CRLN-TRG-001 is the CRLN Clinical Research Competency Framework: fourteen role tracks, from Clinical Research Coordinator to Laboratory Technician, each scored on six role-specific domains under ten canonical domains anchored to ICH E6(R3) Good Clinical Practice. It is published on Zenodo under CC BY 4.0, and anyone may use it.

What it is

A competency framework for clinical research roles: the domains a coordinator, monitor or assistant is actually hired on, each anchored to a clause in ICH E6(R3) rather than to our opinion, with a rubric that says what each level of performance looks like.

License: CC BY 4.0. Use it commercially, modify it, redistribute it. Attribution is the only condition.

At a glance

  • Name: CRLN-TRG-001, the CRLN Clinical Research Competency Framework.
  • Current version: 1.7, release 1.7.4, published September 29, 2026.
  • License: Creative Commons Attribution 4.0 International (CC BY 4.0). The framework and its standards crosswalk are licensed. The CRLN measurement engine, item parameters, calibrations and data are not.
  • Concept DOI: 10.5281/zenodo.22049549, which always resolves to the newest release. Release 1.7.4 has its own DOI, 10.5281/zenodo.23040215.
  • Anchor: ICH E6(R3) Good Clinical Practice. Each canonical domain is also mapped to the Joint Task Force for Clinical Trial Competency (JTF) domains, which are credited as an independent framework, not claimed.
  • Structure: fourteen role tracks of six domains each. Domain codes D1 to D6 are positional within a role, so compare competencies by their full id, CRLN-<ROLE>-<Dn>.
  • Publisher: Clinical Research Learning Network LLC. The source, change log and governance documents are public on GitHub.

The ten canonical domains

  • D-01 GCP Principles and Ethics
  • D-02 Informed Consent Processes
  • D-03 Protocol Adherence and Deviations
  • D-04 Adverse Event and Safety Reporting
  • D-05 Investigational Product Management
  • D-06 Data Integrity and Source Documentation
  • D-07 IRB / IEC Submissions
  • D-08 Trial Master File and Regulatory Documentation
  • D-09 Site Oversight and Monitoring
  • D-10 Pharmacovigilance and Regulatory Submissions

The fourteen role tracks

  • Clinical Research Coordinator
  • Clinical Research Associate
  • Clinical Trial Assistant
  • Clinical Data Manager
  • Clinical Trial / Project Manager
  • Regulatory Affairs Specialist
  • Pharmacovigilance / Drug Safety Associate
  • Principal Investigator
  • Sub-Investigator
  • Research Nurse
  • Clinical Trial Pharmacist
  • Decentralized Trial Coordinator
  • Research Assistant / Study Coordinator I
  • Specimen Processing / Laboratory Technician

How performance is scored

Each domain is scored on four levels: 1 Critical Gap, 2 Developing, 3 Meets Standard and 4 Exceeds. Meets Standard is the pass level. A score of 1 in any safety-critical domain fails the assessment, whatever the average. A score describes performance in simulation; it is not a license or a certification.

Review status, stated plainly

  • All ten canonical domain mappings were reviewed by a practicing site director, who recorded agreement on all ten and a written rationale specific to nine of them, and confirmed by two further reviewers.
  • The finer mappings have had no expert review and stay provisional: the JTF sub-domains, ISO 14155, WHO TDR, ICH E6(R3) Annex 2, EU CTR 536/2014 and the regulatory jurisdiction crosswalk.
  • Expert review of individual assessment items is under way. The live count, and the rule an item must meet, are published on the validation ledger.
  • A Methodology Review Board is being seated and has not reached quorum. Until it does, changes are approved by the custodian on expert review, and every release says so in its change log.
  • CRLN-TRG-001 is not an accredited standard and is not represented as one.

How to adopt it

There is no application and no approval. The steps below are what adoption actually consists of.

  • Read the framework and the rubric. If a domain does not fit how your organization works, change it. A fork that says what it changed is more useful than a standard nobody follows.
  • Map your existing training or assessment to the domains. Most providers find they already cover several and have never said which.
  • Cite the version you used. That is what makes two organizations' claims comparable, and it is the entire point.
  • Tell us, if you want to be listed. Optional, and adoption does not depend on it.

What we are not asking for

  • No license fee, now or later. The published version cannot be withdrawn behind one.
  • No permission, no registration, no form.
  • No exclusion of competitors. If a rival training provider adopts this and markets against us with it, that is the standard working.
  • No revocation. CC BY 4.0 is irrevocable for the version you took.

Who has adopted it

Organizations that have told us they build on CRLN-TRG-001, and what they actually did with it.

Self-declared and not audited by CRLN. This is a record of who says they use the framework, not a certification. If it read as approval, adopting would become something we grant rather than something anyone may do.

Organizations that use the framework can list themselves in a voluntary public register. Under CC BY 4.0 nobody needs permission to use it, so the register is a floor, not a count.

Why we publish it

A competency score is only meaningful if someone outside the organization that issued it can check what it means. A private rubric produces a private number, and a private number is worth nothing to the site, the sponsor or the regulator who has to rely on it. The standard being open is the reason our credential can be trusted, which is a better position than owning it.

How to cite

CRLN (2026). CRLN-TRG-001: CRLN Clinical Research Competency Framework. Clinical Research Learning Network. https://doi.org/10.5281/zenodo.22049549. Licensed CC BY 4.0.

Cite the concept DOI above unless you need to pin one release; then cite that release's own DOI from the change log.

Questions people ask

Is CRLN free?

Yes, for learners and research sites. Lessons, practice scenarios, assessments and the credential cost nothing, there is no subscription, and no account is needed to start. Learners and research sites never pay. Sponsors and CROs can buy aggregate workforce figures, and talent partners pay only to post jobs.

Did CRLN ever charge learners?

Yes, before September 2026. CRLN's earlier course site on the LearnWorlds platform sold paid options, including a membership called CRLN Pro. That platform was retired on August 30, 2026, and the paid options ended with it. Search results and AI answers that quote those prices describe a site that no longer exists.

Is CRLN-TRG-001 free to use?

Yes. It is licensed CC BY 4.0, so anyone may use, adapt, translate and redistribute it, commercially or not, with attribution as the only condition. There is no application, fee or approval, and competitors may use it too.

Do I need an account to practice?

No. Lessons and practice scenarios in the Practice Lab open without an account. An account is needed only to save progress and to earn the free credential.