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GHTF SG5 Clinical Performance Studies for IVD Medical …
www.imdrf.orgClinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices Study Group 5 Final Document GHTF/SG5/N8:2012 November 2nd, 2012 Page 8 of 21 6.1.1 Cross-sectional Designs Cross-sectional clinical performance studies are those where correlation of test results to clinical