Does the Investigator List get filed in the TMF?

Home › Forums › General Discussion Forum › Does the Investigator List get filed in the TMF?

Tagged: 

Viewing 1 reply thread
  • Author
    Posts
    • December 17, 2019 at 5:05 pm #2744
      Rita Klotz
      Participant

      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?

    • December 17, 2019 at 5:26 pm #2745
      Karen Williams
      Participant

      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

  • Author
    Posts
Viewing 1 reply thread
  • You must be logged in to reply to this topic.