definiens: or means all applicable good clinical practicestandards for the design, conduct, performance, monitoring, auditing, recording, analyses andreporting of clinical trials, including, as applicable, ( a ) the International Conference onHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ) Harmonised Tripartite Guideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and anyother 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 AssociationGeneral Assembly in October 2000, and any further amendments or clarifications thereto ; and ( c)the equivalent Applicable Laws in any relevant country, each as may be amended andapplicable from time to time and, in each case, that provide for, among other things, assurancethat the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects