医疗器械临床研究 人类受试者 药物临床试验质量管理规范

[中文适用范围]： 本标准规定了在人体身上进行临床研究以评估医疗器械的临床性能、有效性和安全性的良好临床实践（GCP），涵盖研究的设计、实施、记录与报告。对于上市后的临床研究，应依据研究的性质（参见附件一）遵循本标准所列原则，视相关程度予以适用。 [外文原描述]： This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I ). This document specifies the general requirements intended to protect the rights, safety and well-being of human subjects, users or other persons, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s). NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5] ). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.