The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.

GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.

"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection."

Objectives:

Ensure prompt reporting of safety concerns.

Maintain compliance with ethical oversight requirements.