definiens: or shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and req uirements regarding the ethical conduct of clinical trials, including without limitation the U.S. Code of Feder al Regulations ( ) Title 21, ICH GCP Guidelines E6(R1 ), current step 4 version, dated 10 June 1996, as amended from time to time, national legislation implementing European Community Directive 2001/20 / E C of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Me mber States relating to the implementation of good clinical practice in the conduct of clinical trials on medic inal products for human use, European Community Dir ective 2005/28 / EC of 8 April 2005 laying down principles a nd detailed guidelines for good clinical practice a s regards to investigational medicinal products for human use