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Risk Matrix — Clinical Trial Quality Risks (ICH E6 RBQM, 3×3)

An ICH E6(R3) risk-based quality management assessment for a fictional 2,400-participant phase III trial on a 3×3 matrix: controls cut exposure from 50 to 25 (−50%), take seven of eight critical-to-quality risks down a band, and leave only slow recruitment rated High — above appetite, with 20 extra sites as the treatment. Illustrative register.

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ARIA-3 phase III anticoagulant trial — critical-to-quality risk assessmentRisk-based quality management after ICH E6(R3) · 2,400 participants, 140 sitesHEAT MAP · residual position, arrows from inherent11LOWLOW22LOWLOW33MEDIUMMEDIUM22LOWLOW44MEDIUMMEDIUM66HIGHHIGH33MEDIUMMEDIUM66HIGHHIGH99HIGHHIGHQ6Q7Q8Q2Q3Q4Q5Q7Q8Q1Q3Q4Q5Q6Q1Q2Unlikely1Possible2Likely31Lowno effect on safety orendpoints2Mediumsecondary endpointsor GCP3Highparticipant safety orprimary endpointLIKELIHOOD →IMPACT →R1residual position (after controls)R1inherent positioneffect of existing controlsappetite boundary · red ring = above it9L×I score and rating bandRISK PROFILE BY BANDInherentResidual (current)High6 → 1Medium2 → 4Low0 → 3Low 1–2 · Medium 3–4 · High 6–9EXPOSURE Σ L×I25residual, after current controlsfrom 50 inherent · −50%HIGHEST RESIDUAL RISKQ1Recruitment too slow to reachlast-participant-in by Q3 20276 · Highowner Clinical Operations LeadRISK APPETITEMedium or below1 risk above: Q1Risk register8 risks · sorted by residual rating, then score#IDRISK, CONTROLS AND ACTIONSOWNERINHERENTRESIDUALCHANGEFEASIBILITYRecruitment too slow to reach last-participant-in by Q32027Thirty back-up sites pre-qualifiedCentral recruitment campaign with pre-screening→Open 20 additional sites in Poland and Brazil — due 2027-03 ·Clinical Operations Lead1Q1Clinical OperationsLead3 × 39 · High2 × 36 · HighABOVE APPETITE−3−33%↑ risingDATA RELIABILITYMore than 2% of participants lost to follow-upRetention visits and consent to contact a named relative2Q5Clinical OperationsLead3 × 26 · High2 × 24 · Medium−2−33%PARTICIPANT SAFETYMajor bleeding SAEs reported to the sponsor after 24hourseCRF bleeding events trigger an automatic SAE alertSAE reporting retraining before site activation3Q2PharmacovigilanceLead3 × 39 · High1 × 33 · Medium−6−67%PRIMARY ENDPOINTPrimary endpoint events adjudicated inconsistentlyBlinded central clinical events committee with a written charter4Q3Trial Statistician2 × 36 · High1 × 33 · Medium−3−50%INVESTIGATIONAL PRODUCTInvestigational product exposed to a temperatureexcursionCalibrated temperature loggers with alarms at depots and sitesAutomatic quarantine of excursion kits in the IRT5Q4Supply ChainManager2 × 36 · High1 × 33 · Medium−3−50%ELIGIBILITYParticipants enrolled outside the renal-functioneligibility limitCentral-lab creatinine with eCRF eligibility edit checks6Q6Medical Monitor3 × 26 · High1 × 22 · Low−4−67%BLINDINGInadvertent unblinding through local INR testingSham INR devices and written site instructions7Q7Medical Monitor2 × 24 · Medium1 × 22 · Low−2−50%DATA INTEGRITYSource data back-filled or altered at paper-source sitesCentral statistical monitoring with key risk indicators8Q8Quality AssuranceLead2 × 24 · Medium1 × 22 · Low−2−50%FINDINGS8 risks rated — inherent 6 High, 2 Medium; after current controls 1 High, 4 Medium, 3 Low.Total exposure Σ(L×I) falls from 50 to 25 after current controls — a 50% reduction.Controls move 7 of 8 assessed risks into a lower band; 1 keeps its inherent band.1 of 8 risks sits above the Medium appetite on residual rating — Q1 (High 6); it has a treatment action.Highest residual risk: Q1 Recruitment too slow to reach last-participant-in by Q3 2027 — High 6, owner Clinical Operations Lead.Controls do most for Q2: 9 → 3 (−67%).Illustrative assessment for a fictional trial; risks, controls and ratings are examples for teaching, not a study plan.

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title "ARIA-3 phase III anticoagulant trial — critical-to-quality risk assessment"
subtitle "Risk-based quality management after ICH E6(R3) · 2,400 participants, 140 sites"
likelihood-levels: Unlikely, Possible, Likely
impact-levels: Low (no effect on safety or endpoints), Medium (secondary endpoints or GCP), High (participant safety or primary endpoint)
bands: Low 1-2, Medium 3-4, High 6-9
appetite: Medium
note "Illustrative assessment for a fictional trial; risks, controls and ratings are examples for teaching, not a study plan."

risk Q1 "Recruitment too slow to reach last-participant-in by Q3 2027"
  category: Feasibility
  owner: Clinical Operations Lead
  likelihood: 3
  impact: 3
  control "Thirty back-up sites pre-qualified"
  control "Central recruitment campaign with pre-screening"
  residual: 2x3
  action "Open 20 additional sites in Poland and Brazil" due: 2027-03 owner: "Clinical Operations Lead"
  trend: rising

risk Q2 "Major bleeding SAEs reported to the sponsor after 24 hours"
  category: Participant safety
  owner: Pharmacovigilance Lead
  likelihood: 3
  impact: 3
  control "eCRF bleeding events trigger an automatic SAE alert"
  control "SAE reporting retraining before site activation"
  residual: 1x3

risk Q3 "Primary endpoint events adjudicated inconsistently"
  category: Primary endpoint
  owner: Trial Statistician
  likelihood: 2
  impact: 3
  control "Blinded central clinical events committee with a written charter"
  residual: 1x3

risk Q4 "Investigational product exposed to a temperature excursion"
  category: Investigational product
  owner: Supply Chain Manager
  likelihood: 2
  impact: 3
  control "Calibrated temperature loggers with alarms at depots and sites"
  control "Automatic quarantine of excursion kits in the IRT"
  residual: 1x3

risk Q5 "More than 2% of participants lost to follow-up"
  category: Data reliability
  owner: Clinical Operations Lead
  likelihood: 3
  impact: 2
  control "Retention visits and consent to contact a named relative"
  residual: 2x2

risk Q6 "Participants enrolled outside the renal-function eligibility limit"
  category: Eligibility
  owner: Medical Monitor
  likelihood: 3
  impact: 2
  control "Central-lab creatinine with eCRF eligibility edit checks"
  residual: 1x2

risk Q7 "Inadvertent unblinding through local INR testing"
  category: Blinding
  owner: Medical Monitor
  likelihood: 2
  impact: 2
  control "Sham INR devices and written site instructions"
  residual: 1x2

risk Q8 "Source data back-filled or altered at paper-source sites"
  category: Data integrity
  owner: Quality Assurance Lead
  likelihood: 2
  impact: 2
  control "Central statistical monitoring with key risk indicators"
  residual: 1x2