Mega Socra Ccrp Exam Content With Correct Answers

IDE - Responsibilities of sponsors {Ans: Selecting qualified investigators and providing them with the info they need to conduct the investigation properly Ensuring proper monitoring Ensuring that IRB review and approval are obtained Submitting an IDE application to the FDA Ensuring that any reviewing IRB and FDA are promptly infomred of significant new info about the investigation}Minimal Risk {Ans: Means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3)}What is an in-vtiro diagnostic? {Ans: Way to test for a certain property or result outside the human body}21 CFR 56 {Ans: IRB}What are the phases of device trials? {Ans: 1) Pilot 2) Pivotal}An adverse event that is severe in intensity is considered serious. {Ans: False}Form 3500A {Ans: Mandatory safety reporting by user facilities, distributors, and manufacturers}Investigator- Maintenance of IP records: Investigator/pharmacist should maintain records of {Ans: IP's delivery to the site Invenstory at the site Use by each subject Return to sponsor or alternative disposition of unused products Records