中华人民共和国民法典-20210101
Informed
Consent Guidance for IRBs, Clinical Investigators, and Sponsors-202308
Subjects who cannot write can indicate their consent by "making their mark" on the consent document, in lieu of signing and dating the consent form when consistent with applicable law. In these situations, a note should be included in subject case histories required to be maintained under 21 CFR 312.62(b) or 21 CFR 812.140(a)(3) indicating the reason for the lack of a signature and date as required by 21 CFR 50.27(a). The date consent was obtained should be recorded in this note.
《药品注册核查要点与判定原则（药物临床试验）（试行）》 - 20220101
三（三）1（3）知情同意书中受试者和/或监护人（如需要）、研究者、公平见证人（如需要）的签字和签署时间、签署版本等符合GCP要求。
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