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. It scores what a person does in realistic scenarios, not what they recall, and it is 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.
Continuing education
The Society of Clinical Research Associates (SOCRA — www.socra.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research. SOCRA does not pre-approve or validate individual programs; the candidate is responsible for determining applicability to their SOCRA CE requirements.
Learners maintaining ACRP certification may be able to self-report this training toward certification maintenance if it meets ACRP’s continuing-education criteria (see acrpnet.org). CRLN is not an ACRP-authorized provider and does not award ACRP contact hours.
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 to 2.99 · Fail below. A score of 1 in any safety-critical domain forces an overall FAIL regardless of composite score.
Roles & competency domains
84 competency identifiers of the form CRLN-{ROLE}-D{n}. These are the stable anchors that CRLN verifiable credentials reference.
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CRC-D1 | Protocol Adherence & Eligibility | 0.20 | ICH E6(R3) §2.5 · 21 CFR §312.62 |
| CRLN-CRC-D2 | Informed Consent ProcessSafety-critical | 0.20 | 21 CFR Part 50 · ICH E6(R3) §2.8 |
| CRLN-CRC-D3 | Source Documentation & ALCOA+ | 0.20 | 21 CFR Part 11 · ICH E6(R3) §2.12 · ALCOA+ |
| CRLN-CRC-D4 | Investigational Product Management | 0.15 | ICH E6(R3) §2.10 · 21 CFR §312.59/61 |
| CRLN-CRC-D5 | AE Recognition & ReportingSafety-critical | 0.15 | ICH E6(R3) §2.7.2 · ICH E2A |
| CRLN-CRC-D6 | Communication & Escalation | 0.10 | ICH E6(R3) §2.5 · §3.4 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CRA-D1 | Site Qualification & Feasibility | 0.10 | ICH E6(R3) §3.15.2 · 21 CFR §312.53 |
| CRLN-CRA-D2 | On-Site Monitoring · SDV/SDR | 0.25 | ICH E6(R3) §3.11.4 · FDA RBM Guidance |
| CRLN-CRA-D3 | Protocol Deviation AssessmentSafety-critical | 0.20 | ICH E6(R3) §3.12 · 21 CFR §312.62 |
| CRLN-CRA-D4 | IP Accountability Verification | 0.15 | ICH E6(R3) §3.11.4 · 21 CFR §312.59 |
| CRLN-CRA-D5 | Site Communication & Visit Reporting | 0.20 | ICH E6(R3) §3.11.4 · TransCelerate |
| CRLN-CRA-D6 | Risk-Based Monitoring & Remote Oversight | 0.10 | FDA RBM Guidance 2023 · ICH E6(R3) §3.10 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CTA-D1 | Trial Master File Management | 0.25 | ICH E6(R3) Appendix C · DIA TMF Ref Model v3.0 |
| CRLN-CTA-D2 | Regulatory Submissions & IRB/IEC | 0.20 | 21 CFR §312 · 21 CFR §56 · ICH E6(R3) §3 |
| CRLN-CTA-D3 | Study Start-Up & CTMS | 0.20 | ICH E6(R3) §3.15.2 · CTMS Governance |
| CRLN-CTA-D4 | Data Integrity & 21 CFR Part 11 | 0.15 | 21 CFR Part 11 · ICH E6(R3) §3.16 |
| CRLN-CTA-D5 | Safety Reporting AdministrationSafety-critical | 0.10 | ICH E2A · 21 CFR §312.32 · ICH E6(R3) §3.13 |
| CRLN-CTA-D6 | Quality, Audit Readiness & CAPA | 0.10 | ICH E6(R3) §3.11.2 · 21 CFR §312.68 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-CDM-D1 | Data Management Plan & CRF Design | 0.15 | ICH E6(R3) §3.16 · GCDMP · CDISC CDASH |
| CRLN-CDM-D2 | EDC Build & Validation | 0.15 | 21 CFR Part 11 · ICH E6(R3) §3.16.1 |
| CRLN-CDM-D3 | Data Entry, Query Management & Cleaning | 0.20 | GCDMP · ICH E6(R3) §3.16 |
| 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) §3.16 · 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) §3.10 · §5.13 |
| CRLN-PM-D2 | Site Management & Oversight | 0.20 | ICH E6(R3) §3.11.4 |
| CRLN-PM-D3 | Vendor / CRO Oversight | 0.15 | ICH E6(R3) §3.3 |
| CRLN-PM-D4 | Risk Management & MitigationSafety-critical | 0.20 | ICH E6(R3) §3.10 (RBQM) · FDA RBM |
| CRLN-PM-D5 | Budget & Resource Management | 0.10 | ICH E6(R3) §3.5 |
| CRLN-PM-D6 | Sponsor Communication & Reporting | 0.20 | ICH E6(R3) §3.11.4 · §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) §3.12 · 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) Appendix C |
| 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 · ICH E2A |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-PI-D1 | Investigator Oversight & Delegation | 0.20 | ICH E6(R3) §2.1 · §4.2 |
| CRLN-PI-D2 | Informed Consent OversightSafety-critical | 0.15 | 21 CFR 50 · ICH E6(R3) §2.8 |
| CRLN-PI-D3 | Protocol Conduct & Eligibility | 0.15 | ICH E6(R3) §2.5 |
| CRLN-PI-D4 | Medical Safety & AE AssessmentSafety-critical | 0.20 | ICH E6(R3) §2.7.2 · ICH E2A |
| CRLN-PI-D5 | Source Documentation & Data Integrity | 0.15 | ICH E6(R3) §2.12 · ALCOA+ |
| CRLN-PI-D6 | Regulatory & Ethical Compliance | 0.15 | ICH E6(R3) §2.1 · Declaration of Helsinki |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-SUBI-D1 | Working Within Your Delegated Authority | 0.20 | ICH E6(R3) §2.3 · FDA Form 1572 §6 |
| CRLN-SUBI-D2 | Obtaining & Documenting Informed Consent | 0.15 | ICH E6(R3) §2.9 · 21 CFR Part 50 |
| CRLN-SUBI-D3 | Eligibility Assessment & Protocol Conduct | 0.15 | ICH E6(R3) §2.6 |
| CRLN-SUBI-D4 | Clinical Assessment & AE AttributionSafety-critical | 0.20 | ICH E6(R3) §2.8 |
| CRLN-SUBI-D5 | Contemporaneous Source Documentation | 0.10 | ICH E6(R3) §4.1 · ALCOA+ |
| CRLN-SUBI-D6 | Escalating to the Principal InvestigatorSafety-critical | 0.20 | ICH E6(R3) §2.1 · §2.3 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-RN-D1 | Participant Assessment & Clinical Monitoring | 0.20 | ICH E6(R3) §2.5 · protocol schedule of assessments |
| CRLN-RN-D2 | Study Intervention AdministrationSafety-critical | 0.20 | ICH E6(R3) §2.10 · 21 CFR §312.59/61 |
| CRLN-RN-D3 | Specimen Collection, Handling & Chain of Custody | 0.15 | ICH E6(R3) §2.12 · ALCOA+ · protocol lab manual |
| CRLN-RN-D4 | Adverse Event Recognition & EscalationSafety-critical | 0.20 | ICH E6(R3) §2.11 · ICH E2A |
| CRLN-RN-D5 | Participant Education, Adherence & Support | 0.10 | 21 CFR Part 50 · ICH E6(R3) §2.8 |
| CRLN-RN-D6 | Nursing Documentation & Scope of Practice | 0.15 | ICH E6(R3) §2.3 · ALCOA+ · national nursing regulation |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-PHARM-D1 | IP Receipt, Storage & Temperature Excursions | 0.15 | ICH E6(R3) §2.10 · EU GMP Annex 13 |
| CRLN-PHARM-D2 | Randomization, Blinding & Emergency UnblindingSafety-critical | 0.20 | ICH E6(R3) §2.9 · §2.10 |
| CRLN-PHARM-D3 | Dose Preparation & Compounding AccuracySafety-critical | 0.20 | ICH E6(R3) §2.10 · EU GMP Annex 1 |
| CRLN-PHARM-D4 | IP Accountability, Reconciliation & Destruction | 0.15 | ICH E6(R3) §2.10 · 21 CFR §312.59/62 |
| CRLN-PHARM-D5 | Prescription Review & Dose Verification | 0.15 | ICH E6(R3) §2.10 · protocol dosing schedule |
| CRLN-PHARM-D6 | Pharmacy Documentation & Regulatory Compliance | 0.15 | ICH E6(R3) §2.12 · ALCOA+ · 21 CFR §312.61 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-DCT-D1 | Remote Visit Conduct & Participant Verification | 0.15 | ICH E6(R3) Annex 2 · FDA DCT Guidance 2024 |
| CRLN-DCT-D2 | Remote & Electronic Informed ConsentSafety-critical | 0.20 | 21 CFR Part 11 · 21 CFR Part 50 · ICH E6(R3) §2.8 |
| CRLN-DCT-D3 | Connected Device, Wearable & ePRO Data Integrity | 0.15 | ICH E6(R3) §2.12 · 21 CFR Part 11 · ALCOA+ |
| CRLN-DCT-D4 | Remote Safety Escalation & Home-Nursing OversightSafety-critical | 0.20 | ICH E6(R3) §2.11 · §2.3 · ICH E2A |
| CRLN-DCT-D5 | Direct-to-Participant IP Shipping & Accountability | 0.15 | ICH E6(R3) §2.10 · FDA DCT Guidance 2024 |
| CRLN-DCT-D6 | Decentralised Vendor Oversight & Data Provenance | 0.15 | ICH E6(R3) §2.3 · §2.12 · Annex 2 |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-ASSIST-D1 | Following a Protocol Instruction Exactly | 0.15 | ICH E6(R3) §2.5 · site SOPs |
| CRLN-ASSIST-D2 | Participant Contact & Confidentiality | 0.15 | ICH E6(R3) §2.8 · GDPR / local privacy law |
| CRLN-ASSIST-D3 | Accurate Recording & Transcription | 0.20 | ICH E6(R3) §2.12 · ALCOA+ |
| CRLN-ASSIST-D4 | Recognizing What Must Be ReportedSafety-critical | 0.15 | ICH E6(R3) §2.11 |
| CRLN-ASSIST-D5 | Preparing Visits, Rooms & Supplies | 0.10 | ICH E6(R3) §2.10 · protocol schedule of assessments |
| CRLN-ASSIST-D6 | Knowing the Limit of Your Own AuthoritySafety-critical | 0.25 | ICH E6(R3) §2.3 · delegation log |
| ID | Domain | Weight | Regulatory basis |
|---|---|---|---|
| CRLN-LAB-D1 | Sample Receipt & Identity VerificationSafety-critical | 0.20 | ICH E6(R3) §2.12 · ALCOA+ (attributable) · ISO 15189 |
| CRLN-LAB-D2 | Processing to the Laboratory Manual | 0.20 | ICH E6(R3) §2.5 · protocol laboratory manual |
| CRLN-LAB-D3 | Aliquoting, Labeling & Chain of Custody | 0.20 | ICH E6(R3) §2.12 · ALCOA+ (original, accurate) |
| CRLN-LAB-D4 | Storage, Freezers & Temperature Excursions | 0.15 | ICH E6(R3) §2.12 · ISO 15189 |
| CRLN-LAB-D5 | Shipping, Cold Chain & Dangerous Goods | 0.10 | ICH E6(R3) §2.12 · IATA DGR PI 650 |
| CRLN-LAB-D6 | Deviation Recognition & EscalationSafety-critical | 0.15 | ICH E6(R3) §2.12 · §3.11 |
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
Competency crosswalk: REVIEWED 2026-09-21. All ten canonical domain mappings were reviewed by a practicing site director who recorded a written rationale for each, and confirmed by two further reviewers; reviewers named in GOVERNANCE.md. Corrected 2026-09-28: this field previously said three independent reviewers rated all ten canonical domains and agreed on all ten, unanimously, which was accurate as a count and misleading as a description of the review. Approved by the custodian on that SME review, because the Methodology Review Board has not reached quorum. Jurisdiction and regulatory-regime crosswalk: PROVISIONAL, no SME review has taken place. Assessment items: item-level sign-off is not claimed. The item ratings collected in September 2026 were given while each item's criterion on the public Methodology page named the keyed response (a display removed on 2026-09-29); they are retained, are not described as blind to the key, and do not count toward validation, which counts only ratings given from 2026-09-29 onward. Assessment mechanics (weights, anchors, safety rules, thresholds): CRLN-authored and production-in-use. CRLN-TRG-001 is not an accredited standard and must not be represented as one.
- 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, v1.7.4. 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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