Home Forums Adopting the Reference Model Investigator site file-zones 10 and 11

Viewing 2 reply threads
  • Author
    Posts
    • #3997
      Ilaria Manzari
      Participant

      dear all,
      which kind of documents are expected in the Investigator site file (ISF) for the following artifacts:
      -10.4.1
      -10.4.2
      -10.4.3
      -11.2.6

      in terms of electronic systems validation documentation, do you file them in the ISF?

      thank you
      Ilaria

    • #4001
      Todd Tullis
      Participant

      It is surprising to me that the “Investigator Document” column indicates that Investigator records file into these artifacts. Perhaps this needs to be re-evaluated?

      It is generally not expected to have any ISF records that file to those artifacts in Zone 10, because EDC systems are generally under the control of the Sponsor. If anything, perhaps a system/study specific account access form completed by site staff?

      Likewise for artifact 11.2.6, as this refers to a process that is most often internal to a Sponsor.

    • #4009
      Ilaria Manzari
      Participant

      thanks Todd!I agree it worth reviewing the expected documents in those artifacts of ISF!

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