ชื่อเรื่อง : Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

(คำแนะนำเกี่ยวกับการจัดการการทดลองทางคลินิกในช่วงการระบาดของ COVID-19 (Coronavirus)

หน่วยงาน : European Commission

เนื้อหาโดยย่อ :

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group (GCP IWG), the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities (NCA)) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants1 . Extraordinary measures may need to be implemented and trials adjusted due, among others, to trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infection, and health care professionals being committed to critical tasks.