Stage 1: Define the Question of Interest (QoI)

In accordance with previous ICH, FDA and ISO guidance (ICH Q8(R2); FDA, 2025; ISO 22989), the process should begin by clearly defining the Question of Interest. The Question of Interest can be considered to be the specific question the model is intended to answer. This allows establishment of the decision or insight that will be derived from the model and is vital for all subsequent credibility considerations.