Why does IPD not influence the risk presentation?
By definition, the IPD is a personal evaluation of a potential risk happening:
ICH writes "The sponsor should evaluate the identified risks". "Evaluate" means here - write down your opinion. At the end of the day, it remains as opinion.
Risk detection is the step after a try to mitigate the risks or decision to accept them.
ICH writes: "Predefined quality tolerance limits should be established, taking into consideration the medical and statistical characteristics of the variables as well as the statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial results. Detection of deviations from the predefined quality tolerance limits should trigger an evaluation to determine if action is needed."
There is no hint on IPD here, it tells that a sponsor needs to define QTL (read "risk indicators") and detect the thresholds breaches.
Thus, your IPD is your personal evaluation, and KRI is a data-driven objective detection of risk events. "Data-driven" means that we can rely only on objective information in their presentation. Such as:
- A number of risk events (read: KRIs threshold breaches).
- A frequency of KRIs' threshold breaches.