ICH-GCP 5.3 Participant Safety & Adverse Events(3)

(3)试验的那些方面是 实验性 的。 (4)受试者参与试验的 预期持续时间 。 The consent document must state (ICH GCP 4.8.10): The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant. 同意书必须说明(ICH GCP 4.8.10):对...

(3)提供“免费医疗”,而不是指出参与参与研究的参与者。 (4)发表声明,如“我们将以六个简单的步骤治愈您”。Recruitment of an adequate number of participants...Also, the cost (in time and resources) of retaining and managing a participant who is already enrolled is considerably less than the cost...

Ⅰ、Any concerns regarding participant safety must be addressed immediately by staff at the study site. Ⅱ、The violation and a plan for corrective action must be documented. Ⅲ、The violation must be reported to the principal investigator at the site, the study investigator, project management ...