“When detecting risk, we are detecting risk only on the critical data that was identified, correct? We are not looking at non-critical data for risks, e.g. the fluff?”
IGH GCP Ref: 5.0.4 ; 5.0.5 ; 5.0.6
Risk is typically multi-variate, sometimes we will look at many indicators to get an idea of quality, there is not always a 1:1 relationship. What we are trying to achieve is that we focus our trial activities on those processes and data that are critical to the study success and the protection of subjects and where there is greatest risk of something going wrong.
Sometimes looking at specific critical data could risk unblinding so often detection methods will look around the critical variable e.g. the processes associated with collection. There may well be risks that don’t relate directly to critical data that could impact the study or subjects, this is where past experience is useful either from historic data or from the cross-functional team, but start with what is critical first.