definiens: or means al l applicable good clinical practice standards for the design, conduct, performance, monitoring, a uditing, recording, analyses and reporting of clini cal trials, including, as applicable, ( a ) the International Con ference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmo nised Tripartite Guideline for Good Clinical Practi ce ( CPMP / ICH/135/95 ) and any other applicable guidelin es for good clinical practice for clinical trials o n medicinal products ; ( b ) the Declaration of Helsinki ( 2004 ), a s last amended at the 52nd World Medical Associatio n 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