definiens: or means all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable, ( a ) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ) Harmonised Tripartite 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 amended from time to time and any further amendments or clarifications thereto ; and ( c ) the equivalent Applicable Law in any relevant cou ntry, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects