ISO INTERNATIONAL STANDARD 20916 First edition 2019-05 Invitrodiagnosticmedicaldevices Clinical performance studies using specimens from human subjects Good study practice Dispositifs medicaux de diagnostic in vitro -Etudes des performancescliniques utilisantdesprelevementsdesujetshumains -Bonnespratiquesd'etude Referencenumber IS020916:2019(E) ISO @IS02019 IS020916:2019(E) COPYRIGHTPROTECTEDDOCUMENT IS02019 All rights reserved. Unless otherwise specified, or required in the context ofits implementation, no part of this publication may on the internet or an intranet, without prior writtenpermission.Permission can berequested from either iso at theaddress below or Iso's memberbody in thecountry ofthe requester. ISO copyright office CP 40i:Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax: +41 22 749 09 47 Email:copyright@iso.org Website: www.iso.org Published in Switzerland ii IS0 2019-All rights reserved IS020916:2019(E) Contents Page Foreword .V Introduction .vi 1 Scope .1 2 Normativereferences .1 3 Termsand definitions .2 4 Ethicalconsiderations .11 4.1 General .11 4.2 Improperinfluenceorinducement .11 4.3 Responsibilities.. .11 4.4 Ethicscommitteeinvolvement. .11 4.5 Informed consent. .12 5 Clinicalperformancestudyplanning .12 5.1 General .12 .13 5.2 Riskevaluation 5.3 Design of theclinicalperformancestudy .14 5.4 Investigatorbrochure. .14 5.5 Clinical PerformanceStudyProtocol (CPSP) 15 5.5.1 General .15 5.5.2 Principal investigatorresponsibilities 15 5.5.3 ContentsoftheCPSP 16 5.6 Casereportforms 19 5.7 Recordingofspecimeninformation 20 5.8 Specimenaccountabilityandintegrity 20 5.9 Study site selection 20 5.9.1 Site qualification .20 5.9.2 Siteassessment. 20 5.9.3 Siteselection. 20 5.10 Monitoringplan. .21 5.11 Agreements. 21 5.12 Labelling 21 6 Study site initiation 21 6.1 General. 21 6.2 Prerequisites 22 6.3 Training .22 6.4 Initiation of the studysite 22 7 Clinical performance study conduct .23 7.1 General. 23 7.2 Responsibilitiesofthesponsor 23 7.3 Study site monitoring 23 7.3.1 General. 23 7.3.2 Routinemonitoring 23 7.3.3 Monitoring reports 24 7.4 Security and confidentiality of data 25 8 Close-out oftheclinicalperformance study 25 8.1 Close-out activities 25 8.2 Clinical performancestudy report 25 8.3 Documentretention... 27 8.4 Suspensionorprematureterminationoftheclinicalperformancestudy .27 9 Auditing .28 AnnexA(normative)Additionalgeneralrequirementsforcertainstudies .29 IS0 2019 -All rights reserved ili