Drug administration: Consequence: Consequence: route and rate Likelihood: Likelihood: Risk score: Risk score: Interval between Consequence: Consequence: subjects Likelihood: Likelihood: Risk score: Risk score: Staffing level Consequence: Consequence: required (during/after Likelihood: Likelihood: dosing & other visits. Risk score: Risk score: State requirement for 1st and subsequent doses) IMP/Pharmacy Storage Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: Handling Consequence: Consequence: requirements Likelihood: Likelihood: Risk score: Risk score: Prescribing Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: Safety: general AE/SAE reporting Consequence: Consequence: system Likelihood: Likelihood: Risk score: Risk score: Independent Consequence: Consequence: data/safety Likelihood: Likelihood: monitoring committee Risk score: Risk score: Unblinding procedure Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: IMP Safety: Adverse reactions Add extra rows for all notable AEs AR 1: name, Consequence: Consequence: probability, Likelihood: Likelihood: seriousness, Risk score: Risk score:
Drug administration: route and rate Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Interval between subjects Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Staffing level required (during/after dosing & other visits. State requirement for 1st and subsequent doses) Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: IMP/Pharmacy Storage Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Handling requirements Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Prescribing Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Safety: general AE/SAE reporting system Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Independent data/safety monitoring committee Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Unblinding procedure Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: IMP Safety: Adverse reactions Add extra rows for all notable AEs AR 1: name, probability, seriousness, Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score:
ICRF-OR09-Form-3-v2-Clinical-Risk-Assessment-and-Management-Plan1.docx