Citi Good Clinical Practice Course (Us Fda Focus) Question And Answers Correctly Solved 2023/2024

The new ICH E6(R2) integrated addendum 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? {Ans: Identification of study risks to determine which may safely be omitted from continual monitoring.}Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? {Ans: The study is not intended to be reported to FDA to support a new indication or support a labeling change.}Who is responsible for making the initial risk determination for a device being used in a study? {Ans: The sponsor-investigator.}What is the status of ICH in U.S.? {Ans: It is a FDA guidance.}A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the