Reply To: Types of Tracking Documents in the TMF

[DONATELLA BALLERINI]

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