Types of Tracking Documents in the TMF

[Brenda Emerzian]

Hi All,

Just curious as to what types of Tracking documents you file to this artifact:

Tracking Information Zone-specific documents developed for the purpose of tracking activities during the course of the trial.

I have several site start-up trackers, enrollment trackers, etc. Would checklists be filed under this artifact?

Any suggestions/response will be greatly appreciated.

Brenda

[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

[Brenda Emerzian]

Thank you Donatella for your response. Much appreciated.

Brenda

[Nikita L]

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, 9 months ago by Nikita L. Reason: Notification request by email for replies to this thread

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