Many clinical trials involve the use of medical equipment to measure physiological parameters such as weight or blood pressure. To ensure the accuracy and reliability of these measurements, it is important to properly use and maintain all medical equipment and instrumentation associated with the clinical trial. A plan for meeting routine service and maintenance obligations as well as any quality control or quality assurance requirements should be in place prior to conducting the research.
Supporting documentation for activities such as re-calibration, temperature monitoring, or instrument setting changes (e.g. appropriate date and time zone) should also be maintained. It is also important to ensure staff are appropriately trained on how to use the instrumentation in order to provide accurate results in a safe and effective manner.
Before the equipment is used on any clinical trial subject, it must not only meet the manufacturer’s recommendations for proper functioning but must also meet any essential requirements specified in the protocol.
Adhering to this process will ensure safe and reliable function of the equipment and accurate measurement of the research parameters being evaluated:
Utilize individual manufacturer's recommendations pertaining to service and maintenance needs and reference these in any individual clinical trial research guidelines or procedures
Provide written records of maintenance, temperature logs, calibration logs, etc.
Identify and document where records will be stored
Identify and document who will provide service associated with the specified equipment/instrument
Ensure records are readily available as reference to research teams and audit personnel
NOTE: For equipment not maintained by the research team, verify that relevant ancillary groups (e.g. radiology, diagnostic laboratories) have guidelines in place to ensure the equipment is maintained to an appropriate level.
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