Us Rac Review Questions Raps Modules Questions With Answers

33) According to FDA policy, qualified individuals that are non-MDs can conduct clinical trials as long as an individual listed as a co- or sub-investigator has one of the following credentials is except: A. Doctor of Pharmacy (PharmD) B. Medical Doctor (MD) C. Doctor of Dental Science (DDS) D. Doctor of Osteopathic Medicine (DO) {Ans: A. Doctor of Pharmacy (PharmD) Only PharmD does not treat patients MD, DDS, DO - all treat patients}13) For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? A) Report adverse events under the Medical Device Reporting regulation B) Assisting FDA in communications with the foreign establishment, C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and D) Assisting FDA in scheduling inspections of the foreign establishment. {Ans: A) Report adverse events under the Medical Device Reporting regulation}29) GLP study directors are required to conduct the following activities except: A. Approving the final study reports B. Maintenance of the master schedule C. The protocol is approved and followed D. Experimental data are accurately reported and verified {Ans: B. Maintenance of the master schedule}46) According