The new version of the template for the study participant information sheet (in Dutch: IVO) is now available. This version 1.1, dated 14 August 2026, can now be downloaded from the CCMO website.
Lees meerUnder MDR Ethics Committees nowadays typically ask for a clinical evaluation plan when submitting for review of a clinical investigation. During the last ACS CRA meeting we discussed that this does not concern a new document but rather an exisiting document which is part of the Product Technical File. Below you find the concerning presentation. […]
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