Other templates and documents
Note: The ‘Staff list’ should be used in accordance with the Ordinance on Clinical Trials (ClinO) Annex 3 (1.10, 2.11, 3.9, 4.4) and with the Ordinance on Human Research with the Exception of Clinical Trials (HRO) Annex 2 (1.8, 5.11, 7.9). The ‘staff list’ does not fulfill the requirements set by ICH-GCP E6R2 Art. 4.1.5 and thus it can’t be use as ‘delegation log’.
trials, art. 25 lit. h ClinO
Clinical trials of medical devices, art. 11 ClinO-MD, resp. 1.13 chapter II annex XV MDR
Research projects with persons (non-clinical trials), art. 15 lit. i HRO