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 Ministerial Ordinance on Standards for Implementation of Clinical Studies on Drugs ( GCP Ministerial Ordinance ) by the MHLW, ( b ) the Pharmaceutical and Medical Device Act, ( c ) the International Conference on Harmonisation of Technical Requirements fo r 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 European Union ; ( d ) t he Declaration of Helsinki ( 1964 ) as last amended at the 59th World Medical Association ( WMA ) General Assembly in October 2008 and any further amendments or clarifications thereto ; and ( e ) the equivalent applicable Laws in any relevant country or jurisdict ion, 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 reports results are credible and accurate and protect the rights, integrity, and confidentiality of tr ial subjects