definiens: 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 ) theInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human UseHarmonized Tripartite Guideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and any other applicable guidelines for goodclinical practice for clinical trials on medicinal products, ( b ) the Declaration of Helsinki ( 2004 ), as last amended at the 52ndWorld Medical Association General Assembly in October 2000, and any further amendments or clariﬁcations thereto, and ( c)the equivalent Applicable Laws in any relevant country or region where the clinical trials at issue are being conducted, eachas may be amended and applicable 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 trialsubjects . For clarity, to the extent there is any inconsistency between the foregoing items ( a ), ( b ) and ( c ), the last item ( c)shall control