When a protocol deviation is identified, especially one involving inclusion criteria, the sponsor must be notified immediately. The sponsor will assess the deviation and determine whether the subject can continue in the study. Early notification ensures appropriate action and compliance with protocol and regulatory guidelines.

This answer aligns with GCP principles that mandate sponsor notification in case of protocol deviations, especially when they may impact participant safety or data integrity.

"Any deviation from the protocol that affects subject eligibility must be reported to the sponsor immediately for evaluation and guidance."

Objectives:

Maintain adherence to protocol inclusion criteria.

Report deviations promptly for safety assessment.