Informed consent is a process as stated in Item 1.28 of ICH E6 R2 . No matters if two copies were signed off or a carbon copy was signed off, an auditor needs verify the process, including provision of signed consent forms to the subject/subject’ legal representative, via interview and documentation.  如ICH E6 (R2) 1.28所定义的，知情同意是个过程。因此无论在这过程中签署两份知情同意书，还是一份无碳复写的知情同意书，稽查员都应通过面谈和书面记录来核对这一过程，包括确认受试者/其法定代理人是否也获得了一份经双方签字的知情同意书。（According to Merriam-webster, copy is synonyms of reproduction, duplication）