ICH—Comparison Between ICH GCP E6 and U.S. FDA Regulations Quiz and ans (complete)

What is the legal status of ICH in U.S.? It is a FDA guidance In terms of explaining the probability of assignment to trial arms in consent forms, which is true? ICH notes that it should be included, but does not specify how the information should be presented. The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Identification of study risks to determine which may safely be omitted from continual monitoring.