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Question: If the position of the page number and version date on the footer of a material submitted for ethics is adjusted during printing, such as when the left page number and right version date are used for ethics submission, and the left version date and right page number are used for printing, the theme content remains unchanged, but the material saved by the ethics committee is different from the one saved in the site file. How to define such a problem? What is the impact? How to handle it?

Answer： Consistency emphasizes consistency in content, and differences in printing and layout do not affect it. If the document is a document that requires ethical review and approval according to GCP requirements, such as a plan or informed consent form, in order to avoid misunderstandings caused by formal differences, a written explanation can be submitted to the ethics committee, accompanied by the current version of the document used for the ethics committee's record.