Investigator Site File
ISF documents
- Index 👉🏼 NEW sept 17th 2025
- Contact List
- Clinical Investigational Plan - CIP
- Patient information and consent form - SWE
- Management of AE/SAE
- Ethics Approval SWE
- Ethics Approval ENG
- Medical Agency Approval SWE
- Medical Agency Approval ENG
- Delegation and Signature List
- Training log
- CV's template
- Origin of Source Data
- Monitoring Plan
- Monitoring Visit Log
- Note to File template
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