definiens: or means a set of ethical and scientific quality requirements which mustbe observed for designing, conducting, recording and reporting clinical trials in a given country or group of countries thatinvolve the participation of human subjects including : ( a ) in relation to clinical trials in the European Union, Directive2001/20 / EC, Directive 2001/83 / EC and Directive 2005/28 / EC as well as ICH - GCP and any other guidelines for good clinicalpractice for trials on medicinal products in Europe as amended and applicable from time to time ; ( b ) in relation to clinicaltrials in the U.S., 21 C.F.R. Parts 50 ( Protection of Human Subjects ), 56 ( Institutional Review Boards ) and 312 ( InvestigationalNew Drug Application ), as may be amended from time to time ; and any other guidelines for good clinical practice for trials onmedicinal products in the U.S. as amended and applicable from time to time ; and ( c ) in relation to clinical trials in any othercountry, the equivalent Laws in that country as amended and applicable from time to time