During a monitoring visit, a CRA notices that a piece of equipment required for the...

The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.

GCP guidelines emphasize the PI’s responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.

"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection."

Objectives:

Maintain equipment functionality to ensure data accuracy.

Ensure proper maintenance as part of site management.