The CRC’s first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant’s medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.

According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.

"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making."

Objectives:

Ensure rapid response to dosing errors.

Maintain participant safety as a priority.