The initial certification of equipment and staff, as well as maintenance of this certification, is of utmost importance to assure standard and reliable data collection by clinical sites. Thus, we have developed rigorous certification procedures for clinical site staff and equipment. The certification procedures are documented in our SOP's. The reading center can also be responsible for maintaining site and equipment certifications.
The CRC certification procedures for clinical site staff include test modality-specific exams and rigorous quality assessment of images/data from staff wishing to be certified. Once a technician is certified, we maintain a record on the web interface, and this information is linked to the data during upload, allowing the ability to track which clinical site staff obtained which images/data. The reading center can also be responsible for maintaining site certifications.
Beyond certifying clinical site staff, the equipment that is used to capture the images and data must also be certified under our same rigorous certification procedures. Equipment certification includes analysis of the make and model of the equipment that will be used as well as serial number documentation.