{"id":324,"date":"2022-05-19T16:42:09","date_gmt":"2022-05-19T14:42:09","guid":{"rendered":"https:\/\/wp.unil.ch\/hrp\/?page_id=324"},"modified":"2023-02-22T09:37:57","modified_gmt":"2023-02-22T08:37:57","slug":"soumission","status":"publish","type":"page","link":"https:\/\/wp.unil.ch\/hrp\/en\/soumission\/","title":{"rendered":"Writing & submission"},"content":{"rendered":"
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TIPS! <\/span>Tips<\/span>Use version V1.0 for the first submission to the CER<\/span><\/span><\/span><\/span>\n<\/div>\n\n\n\n

What is the correct Swissethics template for writing my protocol and participant information sheet(s)?<\/p>\n\n\n

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Flowchart to assist with the use of the templates<\/a><\/p>\n\n\n\n

Protocol templates<\/a><\/p>\n\n\n\n

Templates for information and consent sheets<\/a><\/p>\n<\/div>\n\n\n\n

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Which documents do I have to prepare for submission to the ethics committee?<\/p>\n\n\n\n

The list of documents required for submission to the ethics committee depends on the project category<\/strong>. <\/p>\n\n\n\n

Once determined, please refer to one of the lists below.<\/p>\n\n\n\n

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List of documents required to submit a clinical trial (ClinO & ClinO-MD)<\/strong><\/a><\/p>\n<\/div>\n\n\n\n

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List of documents required to submit a different research project (HRO)<\/strong><\/a><\/p>\n<\/div>\n\n\n\n

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In the context of an amendment : How to determine whether it is a substantial amendment?<\/a><\/p>\n<\/div>\n\n\n\n

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I need help<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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How to submit my project?<\/p>\n\n\n\n

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Submission to ethics committees is done via the portal BASEC<\/a> (Business Administration System for Ethics Committees). <\/p>\n<\/div>\n\n\n\n

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Please find below the guides that explain which steps to follow<\/strong> to submit your project via BASEC<\/strong>.<\/p>\n<\/div>\n\n\n\n

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Submission Guide for Clinical Trials with Medical Devices<\/a>Download<\/a><\/div>\n<\/div>\n\n\n\n
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Submission guide for human research projects<\/a>Download<\/a><\/div>\n<\/div>\n\n\n\n
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For research projects for which the CHUV is the sponsor<\/strong>, the submission file must first be submitted to the CHUV's research sponsor's office (BPR) to check its conformity. Regarding the involvement of the BPR<\/strong> via BASEC there are two steps to perform :<\/p>\n\n\n\n

Step 1<\/strong>: Add the BPR as an additional contact<\/p>\n\n\n\n

For this, go to the part 5 \u00ab Addresses \u00bb<\/strong> of BASEC, section \u00ab\u00a0Other contact information\u00a0\u00bb<\/strong> and add the BPR as a primary contact by entering the following information :<\/p>\n\n\n\n

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