What is a KRI threshold?

CYNTEGRITY developed an issue management system (Ticketing system) based on KRIs assisted by CSM. Each time that MyRBQM® Portal detects that a KRI reaches the defined risk threshold, the system triggers an automated alert, an e-mail communication to the person that has been assigned as the risk owner. Thus, immediate risk alerts are distributed to the relevant study team members avoiding delays caused by manual checks and manual communications. The issue management system is designed to document, track and share with the relevant team all preventive and corrective actions, root cause analyses and contingency plans, which are related to an issue. The EarlyBird cloud solution allows a team to timely and efficiently deal with expected and unexpected risk events. Moreover, it provides the essential audit trail, enabling to present a plausible story to auditors: when the issue was triggered, who was involved into its mitigation and what actions were taken.

Two different alert threshold levels have been defined for most KRIs:

  • Medium risk alert threshold – The risk is still under control (risk lower/upper control limits not yet reached), however, there is a relevant increase in the probability of the risk to materialize. This alert informs about the need to deploy preventive actions.
  • High risk alert threshold – The risk has reached the lower or upper risk control limit and corrective actions should be implemented without undue delay

As an example, assuming that for the KRI named “rate of screening failures too high“, the risk control limit is 15 % subject screening failures at a site:

  • Medium risk - KRI threshold is within the risk control limits, e. g., the warning signal will be displayed if 10 % screening failures has been observed
  • High risk - KRI threshold is exactly on or above the risk control limit, e. g., the warning signal will be triggered if 15 % screening failures has been reached or exceeded

The selected KRI thresholds must be documented in a KRI register. KRI thresholds will be determined prior to planning the actions to be implemented, given that risk tolerability will influence the selection of the most suitable preventive & corrective actions (risk response).

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