definiens: or shall mean clinical practice as set out in : ( a ) ICH Harmonised Tripartite Guideline for Good Clinical Pmctice ( CPMP([CHIl35/95 ) and any amendment thereof ; and ( b ) any guidelines concerning good clinical practice pubtished from time to time by the European Commission pursuant to Directive 2001 120lEC or any amendment thereof ; and ( c ) US Code of Federal Regulations Title 21, Parts 50 ( Protection of Human Subjects ) and S6 ( Institutional Review Boards ), as may be amended from time to time ; and " ( d ) the Dec1uration of Helsinki as last amended at the 52nd World Medi cal Association October 2000 and any further amendments thereto : and ( e ) National Institute of Health Standards for the protection of hwnan subjects as may be amended from time to time ; and the equivalent law or regulation in any relevant territory