14 sep Clinical Trial Agreement Switzerland
For clinical trials of certain categories, the sponsor must also report to Swissmedic (see Article 38(5) of the Clinical Trials Regulation). Ethics committees are primarily responsible for assessing compliance with Good Clinical Practice (GCP), scientific merit, inclusion criteria, risk/benefit, ethical aspects of the study, protection of participants, approval procedures, study insurance, contractual agreements, staff and institutional adequacy. Sponsored Clinical Trials: Agreements for sponsored clinical trials in the University Hospitals of Basel (UHB), Bern (Inselspital) and Zurich (USZ) are reviewed and negotiated by the relevant legal department. Please contact the officials of your institution directly.. . .