Home › Forums › General Discussion Forum › sites with zero screen patient or site with zero patient

Tagged: 

Viewing 2 reply threads
  • Author
    Posts
    • September 9, 2021 at 4:34 pm #4243
      Shah Ashraf
      Participant

      Do we include or recommend documents collected for sites with zero screen patient or site with zero patient in the Final TMF. Will it help in Final data Analysis. ?

      Thanks in advance

    • September 23, 2021 at 12:18 pm #4254
      Patricia Fulton
      Participant

      We maintain documents for sites selected but zero patients screened.

    • October 14, 2021 at 6:15 pm #4262
      Jason King-Andreini
      Participant

      Hi Shah,
      If the site was initiated and especially if it has IP on site – requires formal closeout as well. If no screens and screening is closed, send in a CRA to closeout the site.
      Best,
      Jason

  • Author
    Posts
Viewing 2 reply threads
  • You must be logged in to reply to this topic.