Case 2

Investigational Product Quality & Participant Safety

Emerging safety observations and potential investigational medicinal product storage issues require proportionate clinical and quality oversight.

Select the scenario assigned to your group

Scenario 2AInvestigate and contain

Quarantine potentially affected stock, assess exposure and product stability, initiate a medical and quality investigation; consider a targeted hold. Disruption, cost and reputational exposure versus subject protection and defensible continuation.

Open evidence dashboard Scenario 2BDefer additional investigation

Attribute the event provisionally to oncology background and retain routine review. Avoids immediate disruption but risks delayed containment and wider exposure.

Open evidence dashboard

Scenarios are predefined evidence views for the facilitated exercise. The evidence evolution within each scenario is predetermined and released round by round.