- Responsibilities of the National Investigator
- Collaboration agreement with National Principal Investigator (template)
- HOT-ICU contract template
- Approved Protocol
- Trial Synopsis
- EduraCT
- Data Manager Contract with Copenhagen Trial Unit
- Summary of product characteristics
- HOT-ICU Steering Committee
- Monitoring plan
- Data verification plan
- Clinical site contracts (to be announced)
- AID-ICU clinical site duties, clarifications and responsibilities (to be announced)
- Site Initiation check list