definiens: or means all applicable current good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of Clinical Trials, including, as applicable, ( a ) as setforth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use Harmonized Tripartite Guideline for Good Clinical Practice ( CPMP / ICH/135/95 ) and any other applicableguidelines for good clinical practice for trials on medicinal products anywhere in the world, ( b ) the Declaration of Helsinki(2013 ) as last amended at the 64th World Medical Association in October 2013 and any further amendments orclariﬁcations thereto, ( c ) C.F.R. Title 21, Parts 50 ( Protection of Human Subjects ), 56 ( Institutional Review Boards ), and312 ( Investigational New Drug Application ), as may be amended from time to time, and ( d ) any equivalent Applicable Lawin any relevant country, 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