Rac Practice Exam Questions With Correct Answers.

Which of the following is NOT true regarding 21 CFR Part 11? A. Applies to records in electronic form that are created, modified, maintained and archived for regulatory reasons. B. Applies to all electronic records submitted to FDA under the FD&C Act. C. Part 11 will be interpreted narrowly. D. Predicate rule record and record keeping requirements are optional. {Ans: D. Predicate rule record and record keeping requirements are optional. Predicate rule record and record-keeping requirements are enforced.}Under IND/IDE regulations, obligations of a clinical study investigator do NOT include: A. Providing a final study report to the IRB. B. Protecting the rights, safety and welfare of study subjects. C. Controlling the drug under investigation. D. Returning unused supplies of the drug to the sponsor. {Ans: A. Providing a final study report to the IRB. 21 CFR 312.64 - The investigator is not obligated to submit reports to the IRB. Investigators are responsible for submitting reports to the sponsor (i.e. - progress reports, safety reports, a final report).}To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to be: A. In a building separated from other manufacturing buildings. B. In plants that are inspected quarterly. C.