How is the determination of high, intermediate and low processes/data points made? I am used to categorize datapoints as critical and non-critical, which I now realize is a limited approach. Critical data points are those linked to study endpoints (primary, secondary and even tertiary). Critical processes are the processes that allow the capture of critical data points.
The colour-coded SoE can be used during planning at start up but I don't think it's an effective tool during conduct. It's a proxy at best, at worst it's going to confuse CRAs who are used to looking at EDC for outstanding SDV.
How is the determination of high, intermediate and low processes/data points made? I am used to categorize datapoints as critical and non-critical, which I now realize is a limited approach. Critical data points are those linked to study endpoints (primary, secondary and even tertiary). Critical processes are the processes that allow the capture of critical data points.
The colour-coded SoE can be used during planning at start up but I don't think it's an effective tool during conduct. It's a proxy at best, at worst it's going to confuse CRAs who are used to looking at EDC for outstanding SDV.