Does the Investigator List get filed in the TMF?

[Rita Klotz]

Do we file the Investigator List in the TMF? What artifact # if it does?
We need the list in the event of an FDA inspection and, at the end of the study for the CSR Appendix 16 compilation. But where should we file it?

[Karen Williams]

Rita it’s not the norm since I’ve been in the business, however, this listing is constantly updated until final selection has been completed. I would maintain it on a shared drive or a folder on your desk top. Unless requested by upper management to file it in the TMF. However it is not a required document to be filed at trial or country level. I hope this helps

• This reply was modified 4 years, 12 months ago by Karen Williams.

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