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

Todd Tullis

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.