Investigator Site File
ISF documents
- Index
- Clinical Investigational Plan - CIP
- Contact List
- Patient Identification List
- 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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