“How should known Risks be handled? Risks are always identified as potential facts right? I mean errors done with the ICF for example (as not timely approved by ECs although used) are already deviations, not risks.”
ICH GCP Ref: 5.0 ; 5.0.2
I like to think of this using the simple worked example below.
Fact: Known Information e.g. the study drug has a short shelf life due to lack of stability data
Risk: What could go wrong? e.g. Study duration may exceed the shelf-life. What would be the impact? e.g. Cost of re-labelling, cost of manufacturing additional supplies, suspension of subject recruitment and/or treatment, safety concerns and possible impact on results due to treatment interruption. What could be done to mitigate? e.g. Continue with long term stability research; Budget for additional supplies; put plan and forecast in place to detect and monitor when additional supplies/re-labelling will be required to avoid treatment interruption/recruitment suspension.
Issue: What has gone wrong? e.g. Confirmed that study term will exceed shelf-life. What has been affected? e.g. Nothing at this time (as we have forecast and detected the date where mitigations need to become effective) Was it a previously identified risk? Yes What has been done to mitigate? e.g. Budget secured for additional supplies/re-labelling; date for this to become effective has been forecast in advance, process for additional supplies to be shipped/re-labelling to be conducted is in place so time to put plan into effect. Act to resolve: e.g. Implement re-supply/re-labelling plan.
What risk assessment allows us to do is to be proactive and better prepared for dealing with issues before the impact escalates.