swissethics

swissethics Schweizerische Ethikkommissionen f r die Forschung am Menschen Commissions d' thique suisses relative la recherche sur l' tre humain Commissioni etiche svizzere per la ricerca sull'essere umano Swiss Ethics Committees on research involving humans Clinical Protocol template for Investigator initiated trials (IIT): General information and instructions This document is the Clinical Protocol template for IIT (Investigator initiated Trials) studies. swissethics strongly recommends using this template to develop clinical research protocols for trials testing an investigational medicinal product (IMP) or a medical device (MD) to be submitted to Swiss authorities. This template is suitable for studies: - involving IIT, - performed in Switzerland, respectively where the Sponsor-Investigator is located in Switzerland - where the study question does relate to the use of drug(s) or medical device effect(s), - where the Swiss law on therapeutic products (HMG/LPTh and Federal Act on Medicinal Products and medical devices ) applies, - where the Swiss law on human research (Federal Act on Research involving Human Beings (HRA)) and its applicable ordinance ClinO/KlinV/OClin/OSRUm a

Study ID, Version xx of date (DD/MM/YYYY) Page 3 of 45 <<Protocol template: Interventional study with investigational medicinal product (IMP) / medical device …

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  Devices, Medical, Medical device

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