CRLN-TRG-001
CRLN Clinical Research Competency & Assessment Framework
A role-specific, behaviorally-anchored competency assessment framework for entry-level clinical research roles, crosswalked to ICH E6(R3) Good Clinical Practice and 21 CFR, and aligned to the Joint Task Force for Clinical Trial Competency (JTF) domains. Operationalized through scenario-based simulation that scores applied decision-making rather than knowledge recall.
What this is
A role-specific, behaviorally-anchored framework for assessing applied competency — scoring what a person does in realistic scenarios, not what they recall — crosswalked to ICH E6(R3) and 21 CFR.
What this is not
Not a new competency taxonomy. The domains align to the Joint Task Force for Clinical Trial Competency (JTF) — an independent framework CRLN credits and builds upon. CRLN-TRG-001's contribution is the assessment methodology: weights, anchors, safety rules, scoring.
Accreditation & CE Credit
This course can apply towards continuing education (CE) for the Society of Clinical Research Associates (SOCRA — www.SOCRA.org) and for the Association of Clinical Research Professionals (ACRP — www.acrpnet.org) at 1.5 hours of CE credit.
Rating scale
| Level | Label | Meaning |
|---|---|---|
| 1 | Critical Gap | Does Not Meet — regulatory violation or subject-safety risk; would constitute a GCP audit finding. |
| 2 | Developing | Needs Coaching — core task performed with notable gaps; supervisor prompting required. |
| 3 | Meets Standard | Industry Ready — performs all critical behaviours independently; meets GCP minimum standard. |
| 4 | Exceeds | Expert / Leader — Level 3 plus proactive systemic-issue detection, beyond-minimum documentation, and peer coaching. |
Pass ≥ 3 (Industry Ready) · Conditional 2.5–2.99 · Fail below. A score of 1 in any safety-critical domain forces an overall FAIL regardless of composite score.
Roles & competency domains
48 competency identifiers of the form CRLN-{ROLE}-D{n} — the stable anchors that CRLN verifiable credentials reference.
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CRC-D1 | Protocol Adherence & Eligibility | 0.20 | ICH E6(R3) §4.5 · 21 CFR §312.62 |
| CRLN-CRC-D2 | Informed Consent ProcessSafety-critical | 0.20 | 21 CFR Part 50 · ICH E6(R3) §4.8 |
| CRLN-CRC-D3 | Source Documentation & ALCOA+ | 0.20 | 21 CFR Part 11 · ICH E6(R3) §4.9 · ALCOA+ |
| CRLN-CRC-D4 | Investigational Product Management | 0.15 | ICH E6(R3) §4.6 · 21 CFR §312.59/61 |
| CRLN-CRC-D5 | AE Recognition & ReportingSafety-critical | 0.15 | ICH E6(R3) §4.11 · ICH E2A |
| CRLN-CRC-D6 | Communication & Escalation | 0.10 | ICH E6(R3) §4.5 · ICH E6(R3) §3.4 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CRA-D1 | Site Qualification & Feasibility | 0.10 | ICH E6(R3) §5.13 · 21 CFR §312.53 |
| CRLN-CRA-D2 | On-Site Monitoring · SDV/SDR | 0.25 | ICH E6(R3) §5.18 · FDA RBM Guidance 2023 |
| CRLN-CRA-D3 | Protocol Deviation AssessmentSafety-critical | 0.20 | ICH E6(R3) §5.20 · 21 CFR §312.62 |
| CRLN-CRA-D4 | IP Accountability Verification | 0.15 | ICH E6(R3) §5.18.3 · 21 CFR §312.59 |
| CRLN-CRA-D5 | Site Communication & Visit Reporting | 0.20 | ICH E6(R3) §5.18.4 · TransCelerate RBM |
| CRLN-CRA-D6 | Risk-Based Monitoring & Remote Oversight | 0.10 | FDA RBM Guidance 2023 · ICH E6(R3) §5.0 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CTA-D1 | Trial Master File Management | 0.25 | ICH E6(R3) §8.0 · DIA TMF Reference Model v3.0 |
| CRLN-CTA-D2 | Regulatory Submissions & IRB/IEC | 0.20 | 21 CFR Part 312 · 21 CFR Part 56 · ICH E6(R3) §3.0 |
| CRLN-CTA-D3 | Study Start-Up & CTMS | 0.20 | ICH E6(R3) §5.13 |
| CRLN-CTA-D4 | Data Integrity & 21 CFR Part 11 | 0.15 | 21 CFR Part 11 · ICH E6(R3) §5.5 |
| CRLN-CTA-D5 | Safety Reporting AdministrationSafety-critical | 0.10 | ICH E2A · 21 CFR §312.32 · ICH E6(R3) §5.17 |
| CRLN-CTA-D6 | Quality, Audit Readiness & CAPA | 0.10 | ICH E6(R3) §5.19 · 21 CFR §312.68 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CDM-D1 | Data Management Plan & CRF Design | 0.15 | ICH E6(R3) §5.5 · GCDMP · CDISC CDASH |
| CRLN-CDM-D2 | EDC Build & Validation | 0.15 | 21 CFR Part 11 · ICH E6(R3) §5.5.3 |
| CRLN-CDM-D3 | Data Entry, Query Management & Cleaning | 0.20 | GCDMP · ICH E6(R3) §5.5 |
| CRLN-CDM-D4 | Medical Coding (MedDRA/WHODrug) | 0.15 | MedDRA MSSO · WHODrug · ICH E2A |
| CRLN-CDM-D5 | Database Lock & SAE ReconciliationSafety-critical | 0.20 | ICH E6(R3) §5.5 · ICH E2A |
| CRLN-CDM-D6 | CDISC Standards & 21 CFR Part 11 | 0.15 | CDISC SDTM/ADaM · 21 CFR Part 11 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-PM-D1 | Study Planning & Timelines | 0.15 | ICH E6(R3) §5.0 · §5.13 |
| CRLN-PM-D2 | Site Management & Oversight | 0.20 | ICH E6(R3) §5.18 |
| CRLN-PM-D3 | Vendor / CRO Oversight | 0.15 | ICH E6(R3) §5.2 |
| CRLN-PM-D4 | Risk Management & MitigationSafety-critical | 0.20 | ICH E6(R3) §5.0 (RBQM) · FDA RBM |
| CRLN-PM-D5 | Budget & Resource Management | 0.10 | ICH E6(R3) §5.1 |
| CRLN-PM-D6 | Sponsor Communication & Reporting | 0.20 | ICH E6(R3) §5.18.4 · §8 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-RA-D1 | Regulatory Submissions (IND/CTA) | 0.20 | 21 CFR 312 · EU CTR 536/2014 |
| CRLN-RA-D2 | IRB / IEC Interactions | 0.20 | 21 CFR 56 · ICH E6(R3) §3 |
| CRLN-RA-D3 | Protocol Amendments | 0.15 | ICH E6(R3) §5.20 · 21 CFR 312.30 |
| CRLN-RA-D4 | Regulatory Intelligence & Compliance | 0.15 | ICH E6(R3) §2 · §5.0 |
| CRLN-RA-D5 | Safety Reporting to AuthoritiesSafety-critical | 0.20 | 21 CFR 312.32 · ICH E2A |
| CRLN-RA-D6 | Essential Documents & Submissions Filing | 0.10 | ICH E6(R3) §8 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-PV-D1 | Case Intake & Triage | 0.15 | ICH E2A · 21 CFR 314.80 |
| CRLN-PV-D2 | Case Processing & Assessment | 0.20 | ICH E2A · ICH E2D |
| CRLN-PV-D3 | Seriousness / Causality / ExpectednessSafety-critical | 0.20 | ICH E2A · 21 CFR 312.32 |
| CRLN-PV-D4 | Expedited & Periodic ReportingSafety-critical | 0.20 | 21 CFR 312.32 · ICH E2A · ICH E2C |
| CRLN-PV-D5 | MedDRA Coding & Narrative Writing | 0.15 | MedDRA MSSO · ICH E2B |
| CRLN-PV-D6 | Signal Detection & Risk Management | 0.10 | ICH E2E · GVP Module IX |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-PI-D1 | Investigator Oversight & Delegation | 0.20 | ICH E6(R3) §4.1 · §4.2 |
| CRLN-PI-D2 | Informed Consent OversightSafety-critical | 0.15 | 21 CFR 50 · ICH E6(R3) §4.8 |
| CRLN-PI-D3 | Protocol Conduct & Eligibility | 0.15 | ICH E6(R3) §4.5 |
| CRLN-PI-D4 | Medical Safety & AE AssessmentSafety-critical | 0.20 | ICH E6(R3) §4.11 · ICH E2A |
| CRLN-PI-D5 | Source Documentation & Data Integrity | 0.15 | ICH E6(R3) §4.9 · ALCOA+ |
| CRLN-PI-D6 | Regulatory & Ethical Compliance | 0.15 | ICH E6(R3) §4.1 · Declaration of Helsinki |
Regulatory alignment
ICH E6(R3) (adopted 2025-01-06) · 21 CFR Parts 11/50/54/56/312 · ICH E2A · ALCOA+ · DIA TMF Reference Model v3.0. Aligned to the Joint Task Force for Clinical Trial Competency (JTF) — CRLN domains map to JTF competency domains; JTF is an independent framework and is credited, not claimed.
Standards Alignment
CRLN-TRG-001 is aligned with the TransCelerate GCP Mutual Recognition minimum criteria and mapped to ICH E6(R3) and the Joint Task Force competency domains. This is a documented alignment to published standards authored by CRLN, not a third-party audit or validation of CRLN.
- TransCelerate GCP Mutual Recognition minimum criteria
- ICH E6(R3)
- Joint Task Force (JTF) competency domains
Maturity: published, provisional
The competency taxonomy, the four-level scale and the scoring rules are stable and versioned. Two things are not yet independently confirmed, and we would rather you knew which:
- The standards crosswalk (CRLN-TRG-001 ↔ JTF ↔ ICH E6(R3)) is undergoing subject-matter-expert review. 0 of 31 items have been independently attested.
- Regulatory coverage spans 200 jurisdictions, of which 39 are verified against primary sources. The remaining 161 record an inference that the jurisdiction relies on ICH E6(R3) as its GCP baseline.
Licence
The framework and the standards crosswalk are licensed CC BY 4.0. Use, adapt and redistribute it with attribution, commercially included.
The measurement engine, assessment items, their calibrations and the underlying learner data are not licensed here. You may implement the framework; you may not call your scores CRLN Readiness Index scores.
Ownership
CRLN-TRG-001 is authored and maintained by Clinical Research Learning Network LLC, which holds copyright in the framework text and publishes it under the licence above.
Published versions are immutable and each receives its own DOI. Changes are recorded in the public change log below.
Cite as
Clinical Research Learning Network LLC. CRLN-TRG-001: Clinical Research Competency & Assessment Framework, v1.1. 2026. DOI: 10.5281/zenodo.22049549. Licensed CC BY 4.0. Aligned to ICH E6(R3) and the Joint Task Force for Clinical Trial Competency.
Cite the concept DOI for the framework in general — it always resolves to the newest version. Cite a version DOI when you need to pin the exact text you worked from.
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