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?
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