definiens: means all applicable good clinical practice laws, regulations, and standards related to the design, conduct, performance, monitoring, au diting, recording, analyses and reporting of Clinic al Trials, including, as applicable ( a ) as set forth i n the International Conference on Harmonization of Technical Requirements for Registration of Pharmace uticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice ( ICH E6 R2 ) an d any other guidelines related to good clinical practice for trials on medicinal products in the Te rritory, ( b ) the Declaration of Helsinki ( 2004 ) as last amended at the 52nd World Medical Association in Oc tober 2000 and any further amendments or clarifications thereto, ( c ) 21 C.F.R. Parts 50 ( Pro tection of Human Subjects ), 56 ( Institutional Revie w Boards ), and 312 ( Investigational New Drug Applicat ion ), and 42 C.F.R. Part 45 ( Protection of Human Subjects or the Common Rule ), and ( d ) the equivalen t Applicable Law in the region in the Territory, each as applicable from time to time and in each ca se, that provide for, among other things, assurance that the clinical data and reported results are cre dible and accurate and protect the rights, integrit y, and confidentiality of trial subjects