- Responsibilities of the National Investigator
- Collaboration agreement with National Principal Investigator (template)
- AID-ICU contract template
- Approved Protocol
- Trial Synopsis
- Drug Manufacturing Documents
- EduraCT
- Approval from The Danish Medicines Agency
- Approval from Danish Ethics Committee
- Approval from The Danish Data Protection Agency
- Summary of product characteristics
- Trial Patient Insurance
- AID-ICU Steering Committee
- Funding
- 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