Question: ArraySUSAR needs to report to the organization? What actions are expected from it? (GCP No. 57 of 2020, Article 48 (1)) @ @ Institutions assume the role of coordination and quality management in the experiment. If SUSAR is reported to the institution, the institution will receive and review it according to the institution's process. According to Article 17 (6) of the GCP, clinical trial institutions shall establish corresponding internal management departments to undertake the management of clinical trials.
Answer:
机构在试验中承担协调和质量管理的作用。如果SUSAR报机构,机构会按照机构的流程进行接收和审阅。
参见GCP第十七条(六)临床试验机构应当设立相应的内部管理部门,承担临床试验的管理工作。