- Responsibilities of the National Investigator
- Delegation letter (template)
- Collaboration agreement with National Principal Investigator (template)
- CLASSIC contract template
- Approved Protocol
- Trial Synopsis
- EduraCT
- Clinicaltrials.gov: NCT03668236
- Approval from Danish Medicines Agency
- Approval from Danish Ethics Committee
- Summary of product characteristics (in Danish)
- Trial Patient Insurance
- CLASSIC Steering Committee
- Funding
- Monitoring plan
- Data verification plan
- Monitoring agreement
- Clinical site contracts (to be announced)
- CLASSIC clinical site duties, clarifications and responsibilities (to be announced)
- Site Initiation check list.
