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

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 ...

research participants is discussed in the Introduction, Institutional Review Boards, Informed Consent, and Participant Safety and Adverse Events modules...The CCC develops systematic, prioritized, and risk-based (ICH GCP E6(R2) 5.18.3) monitoring plans to be utilized for each CTN study. This plan...

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 。