To address this, I documented the incident, including the subject's identification number, details of the loss, and relevant dates. Given the subject's passing, re-consent is not possible. I immediately informed the principal investigator (PI) and reported the loss to the Institutional Review Board (IRB) as per our hospital's protocols. I reviewed other records, such as progress notes and case report forms, to find any evidence confirming the subject's consent. Additionally, I implemented corrective actions to prevent such occurrences in the future and documented these compliance changes. Lastly, I communicated the incident and the measures taken to the trial sponsor.