Upon receiving their first dose of study drug in the clinic, the subject exhibits an...

In a life-threatening situation, the investigator’s first priority is the safety and well-being of the participant. Administering rescue medication immediately is critical to stabilize the patient, regardless of protocol restrictions. Ethical considerations and patient safety always take precedence over protocol compliance.

GCP guidelines emphasize that subject safety is the primary concern, and appropriate medical care must be administered in emergencies.

"In cases of life-threatening events, the investigator should administer necessary medical interventions to safeguard the subject's health."

Objectives:

Prioritize patient safety in emergency situations.

Make decisions based on medical necessity rather than protocol restrictions.