Risk-based Monitoring - Risk-optimized approaches to clinical trials - Part 3 of 3

[@okola23]

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.

[@eMJeyCGN]

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.