ICH GCP US Trials FDA Requirements скачать в хорошем качестве

ICH GCP US Trials FDA Requirements

Welcome to this module on U.S. Trials and FDA Requirements under Good Clinical Practice (GCP). In this video, we’ll explore how clinical trials conducted in the United States are regulated by the Food and Drug Administration (FDA) to ensure participant safety and data integrity. You’ll learn about key FDA regulations such as 21 CFR Parts 50, 56, 312, and 812, which cover informed consent, ethics committee (IRB) oversight, investigational new drugs (INDs), and medical device trials. We’ll also highlight how FDA inspections, reporting requirements, and compliance expectations align with ICH GCP standards while addressing U.S.-specific obligations. Let’s begin by understanding how FDA regulations guide the ethical and scientific conduct of clinical trials in the United States.