definiens: means all applicable good clinical practice standards for thedesign, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinicaltrials, including, as applicable, ( a ) the International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use Harmonized TripartiteGuideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and any other applicable guidelines forgood clinical practice for clinical trials on medicinal products, ( b ) the Declaration of Helsinki(2004 ), as last amended at the 52nd World Medical Association General Assembly in October2000, and any further amendments or clarifications thereto, and ( c ) the equivalent ApplicableLaws in any relevant country, each as may be amended and applicable from time to time and, ineach case, that provide for, among other things, assurance that the clinical data and reportedresults are credible and accurate and protect the rights, integrity, and confidentiality of trialsubjects