CRF requirements Facilities: specified Consequence: Consequence: rooms or other Likelihood: Likelihood: requirements Risk score: Risk score: Staff: training etc. Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: Additional Risks Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: Consequence: Consequence: Likelihood: Likelihood: Risk score: Risk score: Overall risk (highest impact score if more than one field Revised Risk Score (Post mitigation) completed) Original risk score Completed by Principal Investigator ICRF sign off Post/role in study Name (in capitals) Date Signature Consequence Score Likelihood score Risk score Consequence Score x Likelihood score Insignificant - no obvious harm Rare- Not expected to occur for years Minor - non-permanent harm Unlikely- Expected to occur approx. annually Moderate – semi-permanent harm Possible- Expected to occur approx. monthly Major – major permanent harm or death Likely- Expected to occur approx. weekly Extreme – multiple deaths Almost certain- Expected to occur approx. daily
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
ICRF-OR09-Form-3-v2-Clinical-Risk-Assessment-and-Management-Plan1.docx