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...

They must also be carefully reviewed for every potential participant. 纳入和排除标准精确地定义了哪些人有资格参与研究,哪些人没有资格 。这些标准必须在研究方案中定义。它们还必须为每一个潜在的参与者仔细审查。 Ⅰ、Inclusion criteria are the characteristics that make a potential participant eligible to ...

Ⅱ、Being considerate of the participant’s time. Ⅲ、Identifying and overcoming barriers to retention. Ⅳ、Including retention strategies in the budget. Ⅴ、Identifying and resolving problems in a timely manner. 成功的保留包括: 1、尊重参与者。 2、考虑参与者的时间。 3、 识别和克服保留障碍 。

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 ...