Investigator Site File
- Investigator site file – index
- Contact list
- Protocol v 1.1
- Next of kin information
- Patient information and consent form
- eCRF – Adverse events
- eCRF – Follow up
- eCRF – inhospital
- eCRF – prehospital
- eCRF – randomization
- Patient identification list
- Trial management manual
- Checklist for neurological prognostication
- Manual for neurological prognostication
- Follow up manual
- Instructions for protocol deviations
- Serious adverse events
- Ethics Committee Approval
- CV template
- Signature and delegation list
- Origin of source data