Hi Brenda, in the Tracking Information Zone specific section, I was used to file any tracker content specific to the TMF Zone. Just to give you an example: under artifact 03.04.02 Regulatory I used to file the Regulatory Tracker/Log of all the submission/approval process of the clinical trial. Checklist if used as trackers can be filed in this artifact as well. I hope my example can help you. Donatella
We use 05.05.02 to file all delegation logs during the study, so that the final one can be filed in 05.02.18 when the site is closed. The ones filed in Tracking information have ‘Interim’ added to the file name.
This reply was modified 1 year, 4 months ago by Nikita L. Reason: Notification request by email for replies to this thread