Ordinance
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Art. 57
1 For notifications and reporting in the case of clinical trials of transplantation, Articles 37–41, 43 and 44 apply mutatis mutandis.45 2 The obligations which must be fulfilled under these provisions vis-à-vis the Agency are to be fulfilled, for clinical trials of transplantation, vis-à-vis the FOPH. 3 For clinical trials of transplantation, the duties of the sponsor and the investigator concerning documentation, traceability and retention of records are governed by Articles 34 and 35 of the Transplantation Act. 45 Correction of 27 Dec. 2013 (AS 2013 5579). |