根据Good Clinical Practice (GCP)的概念：GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. 涉及到人的研究，原则上都需遵守GCP要求。在研究者发起的研究中，研究者必须同时承担GCP中规定的申办者的职责。具体可参见ICH E6 R(2)中“Sponsor-Investigator”的定义。