The PI did not record the relationship to IP in the medical chart when assessing...

The PI is responsible for ensuring accurate documentation of adverse events (AEs) in the medical chart, including their relationship to the investigational product (IP). If an omission is identified, the PI must correct it by making a dated and signed amendment to maintain data accuracy and completeness.

GCP guidelines state that the PI must maintain accurate and complete records, including the assessment of the relationship between AEs and the IP.

"The investigator must document the assessment of the relationship between the AE and the investigational product to ensure accurate clinical records."

Objectives:

Maintain accuracy in adverse event documentation.

Ensure data integrity through appropriate corrections.