{
  "$schema": "https://crln-learn.com/schemas/competency-framework/v1.json",
  "framework_id": "CRLN-TRG-001",
  "framework_name": "CRLN Clinical Research Competency & Assessment Framework",
  "version": "1.1",
  "status": "published-provisional",
  "publisher": "Clinical Research Learning Network (CRLN)",
  "license": "CC-BY-4.0",
  "readiness_index": "CRLN-RUB-1.1",
  "description": "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.",
  "alignment": {
    "ich_gcp": "ICH E6(R3) (adopted 2025-01-06)",
    "regulatory": [
      "21 CFR Parts 11/50/54/56/312",
      "ICH E2A",
      "ALCOA+",
      "DIA TMF Reference Model v3.0"
    ],
    "competency_reference": "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.",
    "validation_status": "CRLN-authored rubric (weights, anchors, safety rules, thresholds) is production-in-use. The standards-citation crosswalk is undergoing subject-matter-expert validation; items not yet SME-signed are flagged provisional. Do not represent as an accredited standard until SME validation is complete.",
    "standards_alignment": {
      "standards": [
        "TransCelerate GCP Mutual Recognition minimum criteria",
        "ICH E6(R3)",
        "Joint Task Force (JTF) competency domains"
      ],
      "basis": "Documented mapping of CRLN-TRG-001 competencies to published standards",
      "audited_by_third_party": false,
      "statement": "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."
    }
  },
  "scale": [
    {
      "level": 1,
      "label": "Critical Gap",
      "description": "Does Not Meet — regulatory violation or subject-safety risk; would constitute a GCP audit finding."
    },
    {
      "level": 2,
      "label": "Developing",
      "description": "Needs Coaching — core task performed with notable gaps; supervisor prompting required."
    },
    {
      "level": 3,
      "label": "Meets Standard",
      "description": "Industry Ready — performs all critical behaviours independently; meets GCP minimum standard."
    },
    {
      "level": 4,
      "label": "Exceeds",
      "description": "Expert / Leader — Level 3 plus proactive systemic-issue detection, beyond-minimum documentation, and peer coaching."
    }
  ],
  "scoring": {
    "pass_threshold": 3.0,
    "conditional_pass_threshold": 2.5,
    "safety_rule": "A score of 1 in any safety-critical domain forces an overall FAIL regardless of composite score.",
    "composite": "Weighted mean of covered domain scores, re-normalized against actual covered weight so partial assessments are not penalized (CRLN-RUB-1.1 §5.2).",
    "readiness_index": "Composite (1–4) mapped to a 0–100 Readiness Index via CRLN-RUB-1.1 rubricScoreToPercent."
  },
  "roles": {
    "CRC": {
      "title": "Clinical Research Coordinator — Site Operations & Subject Management",
      "domains": [
        {
          "id": "CRLN-CRC-D1",
          "code": "D1",
          "label": "Protocol Adherence & Eligibility",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.5",
            "21 CFR §312.62"
          ]
        },
        {
          "id": "CRLN-CRC-D2",
          "code": "D2",
          "label": "Informed Consent Process",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "21 CFR Part 50",
            "ICH E6(R3) §4.8"
          ]
        },
        {
          "id": "CRLN-CRC-D3",
          "code": "D3",
          "label": "Source Documentation & ALCOA+",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "21 CFR Part 11",
            "ICH E6(R3) §4.9",
            "ALCOA+"
          ]
        },
        {
          "id": "CRLN-CRC-D4",
          "code": "D4",
          "label": "Investigational Product Management",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.6",
            "21 CFR §312.59/61"
          ]
        },
        {
          "id": "CRLN-CRC-D5",
          "code": "D5",
          "label": "AE Recognition & Reporting",
          "weight": 0.15,
          "safety_critical": true,
          "refs": [
            "ICH E6(R3) §4.11",
            "ICH E2A"
          ]
        },
        {
          "id": "CRLN-CRC-D6",
          "code": "D6",
          "label": "Communication & Escalation",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.5",
            "ICH E6(R3) §3.4"
          ]
        }
      ]
    },
    "CRA": {
      "title": "Clinical Research Associate — Monitoring, Site Oversight & Compliance",
      "domains": [
        {
          "id": "CRLN-CRA-D1",
          "code": "D1",
          "label": "Site Qualification & Feasibility",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.13",
            "21 CFR §312.53"
          ]
        },
        {
          "id": "CRLN-CRA-D2",
          "code": "D2",
          "label": "On-Site Monitoring · SDV/SDR",
          "weight": 0.25,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.18",
            "FDA RBM Guidance 2023"
          ]
        },
        {
          "id": "CRLN-CRA-D3",
          "code": "D3",
          "label": "Protocol Deviation Assessment",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "ICH E6(R3) §5.20",
            "21 CFR §312.62"
          ]
        },
        {
          "id": "CRLN-CRA-D4",
          "code": "D4",
          "label": "IP Accountability Verification",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.18.3",
            "21 CFR §312.59"
          ]
        },
        {
          "id": "CRLN-CRA-D5",
          "code": "D5",
          "label": "Site Communication & Visit Reporting",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.18.4",
            "TransCelerate RBM"
          ]
        },
        {
          "id": "CRLN-CRA-D6",
          "code": "D6",
          "label": "Risk-Based Monitoring & Remote Oversight",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "FDA RBM Guidance 2023",
            "ICH E6(R3) §5.0"
          ]
        }
      ]
    },
    "CTA": {
      "title": "Clinical Trial Assistant — Regulatory Operations, TMF & Study Start-Up",
      "domains": [
        {
          "id": "CRLN-CTA-D1",
          "code": "D1",
          "label": "Trial Master File Management",
          "weight": 0.25,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §8.0",
            "DIA TMF Reference Model v3.0"
          ]
        },
        {
          "id": "CRLN-CTA-D2",
          "code": "D2",
          "label": "Regulatory Submissions & IRB/IEC",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "21 CFR Part 312",
            "21 CFR Part 56",
            "ICH E6(R3) §3.0"
          ]
        },
        {
          "id": "CRLN-CTA-D3",
          "code": "D3",
          "label": "Study Start-Up & CTMS",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.13"
          ]
        },
        {
          "id": "CRLN-CTA-D4",
          "code": "D4",
          "label": "Data Integrity & 21 CFR Part 11",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "21 CFR Part 11",
            "ICH E6(R3) §5.5"
          ]
        },
        {
          "id": "CRLN-CTA-D5",
          "code": "D5",
          "label": "Safety Reporting Administration",
          "weight": 0.1,
          "safety_critical": true,
          "refs": [
            "ICH E2A",
            "21 CFR §312.32",
            "ICH E6(R3) §5.17"
          ]
        },
        {
          "id": "CRLN-CTA-D6",
          "code": "D6",
          "label": "Quality, Audit Readiness & CAPA",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.19",
            "21 CFR §312.68"
          ]
        }
      ]
    },
    "CDM": {
      "title": "Clinical Data Manager — Data Management, EDC & Database Lock",
      "domains": [
        {
          "id": "CRLN-CDM-D1",
          "code": "D1",
          "label": "Data Management Plan & CRF Design",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.5",
            "GCDMP",
            "CDISC CDASH"
          ]
        },
        {
          "id": "CRLN-CDM-D2",
          "code": "D2",
          "label": "EDC Build & Validation",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "21 CFR Part 11",
            "ICH E6(R3) §5.5.3"
          ]
        },
        {
          "id": "CRLN-CDM-D3",
          "code": "D3",
          "label": "Data Entry, Query Management & Cleaning",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "GCDMP",
            "ICH E6(R3) §5.5"
          ]
        },
        {
          "id": "CRLN-CDM-D4",
          "code": "D4",
          "label": "Medical Coding (MedDRA/WHODrug)",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "MedDRA MSSO",
            "WHODrug",
            "ICH E2A"
          ]
        },
        {
          "id": "CRLN-CDM-D5",
          "code": "D5",
          "label": "Database Lock & SAE Reconciliation",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "ICH E6(R3) §5.5",
            "ICH E2A"
          ]
        },
        {
          "id": "CRLN-CDM-D6",
          "code": "D6",
          "label": "CDISC Standards & 21 CFR Part 11",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "CDISC SDTM/ADaM",
            "21 CFR Part 11"
          ]
        }
      ]
    },
    "PM": {
      "title": "Clinical Trial / Project Manager — Study Oversight, Site & Vendor Management, Risk",
      "domains": [
        {
          "id": "CRLN-PM-D1",
          "code": "D1",
          "label": "Study Planning & Timelines",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.0",
            "§5.13"
          ]
        },
        {
          "id": "CRLN-PM-D2",
          "code": "D2",
          "label": "Site Management & Oversight",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.18"
          ]
        },
        {
          "id": "CRLN-PM-D3",
          "code": "D3",
          "label": "Vendor / CRO Oversight",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.2"
          ]
        },
        {
          "id": "CRLN-PM-D4",
          "code": "D4",
          "label": "Risk Management & Mitigation",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "ICH E6(R3) §5.0 (RBQM)",
            "FDA RBM"
          ]
        },
        {
          "id": "CRLN-PM-D5",
          "code": "D5",
          "label": "Budget & Resource Management",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.1"
          ]
        },
        {
          "id": "CRLN-PM-D6",
          "code": "D6",
          "label": "Sponsor Communication & Reporting",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.18.4",
            "§8"
          ]
        }
      ]
    },
    "RA": {
      "title": "Regulatory Affairs Specialist — Regulatory Submissions, IRB/IEC & Safety Reporting",
      "domains": [
        {
          "id": "CRLN-RA-D1",
          "code": "D1",
          "label": "Regulatory Submissions (IND/CTA)",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "21 CFR 312",
            "EU CTR 536/2014"
          ]
        },
        {
          "id": "CRLN-RA-D2",
          "code": "D2",
          "label": "IRB / IEC Interactions",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "21 CFR 56",
            "ICH E6(R3) §3"
          ]
        },
        {
          "id": "CRLN-RA-D3",
          "code": "D3",
          "label": "Protocol Amendments",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §5.20",
            "21 CFR 312.30"
          ]
        },
        {
          "id": "CRLN-RA-D4",
          "code": "D4",
          "label": "Regulatory Intelligence & Compliance",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §2",
            "§5.0"
          ]
        },
        {
          "id": "CRLN-RA-D5",
          "code": "D5",
          "label": "Safety Reporting to Authorities",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "21 CFR 312.32",
            "ICH E2A"
          ]
        },
        {
          "id": "CRLN-RA-D6",
          "code": "D6",
          "label": "Essential Documents & Submissions Filing",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §8"
          ]
        }
      ]
    },
    "PV": {
      "title": "Pharmacovigilance / Drug-Safety Associate — Case Processing, Causality & Expedited Reporting",
      "domains": [
        {
          "id": "CRLN-PV-D1",
          "code": "D1",
          "label": "Case Intake & Triage",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E2A",
            "21 CFR 314.80"
          ]
        },
        {
          "id": "CRLN-PV-D2",
          "code": "D2",
          "label": "Case Processing & Assessment",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E2A",
            "ICH E2D"
          ]
        },
        {
          "id": "CRLN-PV-D3",
          "code": "D3",
          "label": "Seriousness / Causality / Expectedness",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "ICH E2A",
            "21 CFR 312.32"
          ]
        },
        {
          "id": "CRLN-PV-D4",
          "code": "D4",
          "label": "Expedited & Periodic Reporting",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "21 CFR 312.32",
            "ICH E2A",
            "ICH E2C"
          ]
        },
        {
          "id": "CRLN-PV-D5",
          "code": "D5",
          "label": "MedDRA Coding & Narrative Writing",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "MedDRA MSSO",
            "ICH E2B"
          ]
        },
        {
          "id": "CRLN-PV-D6",
          "code": "D6",
          "label": "Signal Detection & Risk Management",
          "weight": 0.1,
          "safety_critical": false,
          "refs": [
            "ICH E2E",
            "GVP Module IX"
          ]
        }
      ]
    },
    "PI": {
      "title": "Principal Investigator / Sub-Investigator — Investigator Oversight, Consent & Medical Safety",
      "domains": [
        {
          "id": "CRLN-PI-D1",
          "code": "D1",
          "label": "Investigator Oversight & Delegation",
          "weight": 0.2,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.1",
            "§4.2"
          ]
        },
        {
          "id": "CRLN-PI-D2",
          "code": "D2",
          "label": "Informed Consent Oversight",
          "weight": 0.15,
          "safety_critical": true,
          "refs": [
            "21 CFR 50",
            "ICH E6(R3) §4.8"
          ]
        },
        {
          "id": "CRLN-PI-D3",
          "code": "D3",
          "label": "Protocol Conduct & Eligibility",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.5"
          ]
        },
        {
          "id": "CRLN-PI-D4",
          "code": "D4",
          "label": "Medical Safety & AE Assessment",
          "weight": 0.2,
          "safety_critical": true,
          "refs": [
            "ICH E6(R3) §4.11",
            "ICH E2A"
          ]
        },
        {
          "id": "CRLN-PI-D5",
          "code": "D5",
          "label": "Source Documentation & Data Integrity",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.9",
            "ALCOA+"
          ]
        },
        {
          "id": "CRLN-PI-D6",
          "code": "D6",
          "label": "Regulatory & Ethical Compliance",
          "weight": 0.15,
          "safety_critical": false,
          "refs": [
            "ICH E6(R3) §4.1",
            "Declaration of Helsinki"
          ]
        }
      ]
    }
  },
  "notes": [
    "18 competency IDs total (3 roles × 6 domains). These IDs are the stable anchors that CRLN-issued verifiable credentials reference (moat build #1).",
    "Domain weights sum to 1.00 within each role and reflect regulatory significance and frequency of GCP findings.",
    "This JSON is the machine-readable form of the CRLN-TRG-001 v1.0 specification; the human-readable spec and change log live alongside it."
  ],
  "domain_code_semantics": "Domain codes D1-D6 are POSITIONAL WITHIN A ROLE. D1 for a CRA and D1 for a CDM are different competencies. Compare using the fully-qualified id (CRLN-<ROLE>-<Dn>), never the bare code."
}