ISO INTERNATIONAL STANDARD 14199 Firstedition 2015-09-15 Health informatics Information models Biomedical Research Integrated Domain Group (BRIDG) Model Informatique de santé - Modele d'information Modele de groupe de domaine intégré de recherche biomeédicale (BRIDG) Reference number ISO 14199:2015(E) LSO International Organization for Standardization @ IS0 2015 dardization 5956617 vided by IHS under ted without license from IHS IS0 14199:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. IsOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+41 22 749 0111 Fax +41 22 749 09 47 [email protected] www.iso.org Intenatinair brganizationfor Standardization Not for Resale, 2015/11/11 08:57:03 networking permitted without license from IHS IS0 14199:2015(E) Contents Page Foreword ..iv Introduction. 1 Scope. 2 Normative references 3 Terms and definitions 4 Abbreviated terms ..2 5 Overview of conceptual representations of the BRIDG model ..2 6 UML-based canonical representations ..4 6.1 General considerations ..4 6.2 Sub-domain UML views. ..4 6.2.1 Common .4 6.2.2 Adverse event. 6.2.3 Protocol representation .4 6.2.4 Regulatory ..4 6.2.5 Statistical analysis. .5 6.2.6 Study conduct. 6.3 UML-based models and views. .5 7 RIM-based HL7 representation .5 7.1 General considerations. ..5 7.2 RIM-based models .6 8 Ontological oWL-based representation > 6 Other additional information .1 9.1 1 UsesofBRIDG 9.2 User's guide for the BRIDG model .7 9.3 Release notes.. .1 9.4 BRIDG maintenance process .7 9.5 BRIDG change list. .7 Bibliography 8 iii see=Zhejiang Institute of Standardization 5956617 vided by IHS under lic cense with ISC ithout license from IHS

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