definiens: or means all applicable good clinical practice stand ards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical tria ls, including, as applicable, ( a ) the International Conference on Harmonisation of Technical Requirements for Registr ation of Pharmaceuticals for Human Use ( ) Harmonised Tr ipartite Guideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and any other guidelines for good clinical practice for clinical trials on medicinal products in the EU ; ( b ) the Declaration of Helsinki ( 2004 ), as last amended at the 52nd World Medical Associati on General Assembly in October 2000, and any further amendment s or clarifications thereto ; and ( c ) the equivalent Applicable Laws in any relevant country, each as may be amende d and applicable from time to time and, in each cas e, that provide for, among other things, assurance that the clinical data and reported results are credible an d accurate and protect the rights, integrity, and confidentiality of trial subjects