definiens: or means all applicable goodclinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, ( a ) theInternational Conference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use ( ) Harmonised Tripartite Guideline for Good ClinicalPractice ( CPMP / ICH/135/95 ) and any other guidelines for good clinical practice for clinicaltrials on medicinal products in the EU ; ( b ) the Declaration of Helsinki ( 2004 ) as last amendedat the 52nd World Medical Association in October 2000 and any further amendments orclarifications thereto ; and ( c ) the equivalent Applicable Laws in any relevant country, each asmay be amended and applicable from time to time and in each case, that provide for, amongother things, assurance that the clinical data and reported7 results are credible and accurate and protect the rights, integrity, and confidentiality of trialSubjects