I would like to ask you, what is your opinion regarding the following:
1. Is it correct to file Calibration certificates for study equipment used for study testing (i.e ECG machine, CT scan, tonometer, body thermometer, centrifuge etc) to 08.01.02?
2. Where should Calibration certificates for equipment used for control of IMP/NIMP storage (min/max thermometers, temperature monitors) be filed – there is no applicable section in DIA model. Is it correct to file them to 06.04.03 as this artifact is dedicated only for device studies?
We do not file calibration certificates in the TMF. We ensure that the CRAs are verifying that the site has calibration certificates when they are on-site and then documenting that in their visit reports. I look forward to hearing how others have handled this. Thanks!