Investigator Site File

The complete Investigator Site File (ISF) will be shared with the site via email before study start. The documents below should be completed by the site and filed in the ISF. 

Documents
ISF index with instructions
18 Sep 2023 ‐
Delegation and Signature List
22 May 2023 ‐
CV template

Another template with similar information can be used.

22 May 2023 ‐
Origin of Source Data
22 May 2023 ‐
Patient identification list
15 Sep 2023 ‐
Contact list for followup

To be completed at the ICU. 

18 Sep 2023 ‐
Contact list for the extended followup substudy

To be completed by ICUs participating in the extended followup substudy.

18 Sep 2023 ‐
Monitoring visit log

Completed by the monitor and signed by site staff at monitoring visits.

25 Nov 2024 ‐