Which of the following reports should be retained in participant charts?

Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP). Therefore, they must be retained in the participant’s medical records.

According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.

"Lab reports must be maintained as part of the participant’s chart for safety monitoring and data verification."

Objectives:

Maintain comprehensive medical records for each participant.

Ensure availability of clinical data for audit and review.