Investigator site file-zones 10 and 11

[Ilaria Manzari]

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

[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.

[Ilaria Manzari]

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

[Author]

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