RAPS Practice Test Questions with 100% Correct Answers

RAPS Practice Test Questions with 100% Correct Answers A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented 1/3 of its subjects properly. What is the FIRST thing the company needs to do? A. Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator at that site on GCP D. Re-consent all improperly consented subjects - Correct Answer D. Re-consent all improperly consented subjects The quality assurance manager of a small company with 12 employees is the company's only internal auditor and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because: A. Auditor independence has not been ensured B. There is no one in the company qualified to train the quality assurance manager in quality auditing principles C. Quality system audits cannot be performed by the same auditor for more than two audits in a row D. The Audit Reports need to be approved by a second internal auditor not involved with the specific audit - Correct Answer A. Auditor independence has not been ensured A medical device company is developing a product with drug, biologic and device components. The product and indication have not been classified previously by FDA. What is the most appropriate regulatory pathway? A. An IDE and PMA should be submitted to CDRH, as the company is a medical device company and is most familiar with medical device application regulations B. A Request for Designation (RFD) should be sent to Office of Combination Products (OCP) at FDA to determine primary mode of action (PMOA) and assign center with primary jurisdiction C. An IND and NDA should be submitted to CBER because this is the strictest regulatory pathway D. The company should submit a marketing application to the appropriate FDA center based on the company's determination of primary mode of action (PMOA) - Correct Answer B. A Request for Designation (RFD) should be sent to Office of Combination Products (OCP) at FDA to determine primary mode of action (PMOA) and assign center with primary jurisdiction