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• ethical review application for researches involved human being
• study protocol
• data collection forms, case report forms, patient diaries, etc
• informed consent form(s)
• patient recruitment materials
• cv of principal investigator
• statement of planned tasks
• letter of intention for co-operation
• site list
• site profile
• investigator brochure
• product literature
• insurance policy (if any)
• other additional documents upon request
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