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:
potential long term consequences AR 2: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: AR 3: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: AR 4: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Invasive procedures/NIMPs adverse reactions Add extra rows for all notable ARs Procedure/NIMP 1: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Procedure/NIMP 2: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Procedure/NIMP 3: name, probability, seriousness, potential long term consequences Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Participants Patient/HV, special requirements, GP medical history, TOPS etc. Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score:
CRF requirements Facilities: specified rooms or other requirements Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Staff: training etc. Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Additional Risks Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Consequence: Likelihood: Risk score: Overall risk (highest impact score if more than one field completed) Revised Risk Score (Post mitigation) Original risk score Completed by Principal Investigator ICRF sign off Post/role in study Name (in capitals) Date Signature Consequence Score Insignificant - no obvious harm Minor - non-permanent harm Moderate – semi-permanent harm Major – major permanent harm or death Extreme – multiple deaths Likelihood score Rare- Not expected to occur for years Unlikely- Expected to occur approx. annually Possible- Expected to occur approx. monthly Likely- Expected to occur approx. weekly Almost certain- Expected to occur approx. daily Risk score Consequence Score x Likelihood score