The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol. Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol’s technical requirements is crucial for the trial’s success.

GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.

"The investigator must have adequate resources, including access to required equipment, to perform the study as specified."

Objectives:

Ensure site readiness for protocol requirements.

Prevent protocol deviations due to inadequate resources.