Hi – If anyone has insight into this question I would be interested to hear. I know the ref model 3.3 has started to account for this – systems validated for use on the trial that are not EDC/CDMS or IRT – eCOA, devices, RBQM etc. Where do you file the requirements, UAT documents etc.?
Are TMF teams implementing a Zone 12 for this now, or filing everything in Zone 10?
Thanks!