AEs that occur between study visits of a clinical trial should be evaluated by the:

The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP). Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.

GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.

"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care."

Objectives:

Ensure prompt and accurate evaluation of AEs.

Maintain the safety and well-being of study participants.