CCRP SOCRA Practice Exam 2024 Final questions and correct answers, Exams of Nursing

Download CCRP SOCRA Practice Exam 2024 Final questions and correct answers and more Exams Nursing in PDF only on Docsity! CCRP SOCRA Practice Exam 2024 Final questions and correct answers The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator - CORRECT ANSWER-C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - CORRECT ANSWER-B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject B) Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject C) For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. D) All the above - CORRECT ANSWER-D ) All of the above With respect to IRB/IEC membership, both the FDA and the ICH require that: A) A majority of the members' primary area of interest is in a scientific area B) At least one member holds a Ph.D. degree or equivalent C) At least one member's primary area of interest is in a nonscientific area D) A majority of the members are from or have ties to the institution of record - CORRECT ANSWER-C) At least one member's primary area of interest is in a nonscientific area In a non-emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval? A) The investigator provides his/her written approval B) The study drug has an FDA approved marketing application C) The FDA provides written approval of the IND D) Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-D) Subjects cannot be enrolled until IRB/IEC approval has been obtained A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? A) This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm B) This subject should undergo all study procedures as outlined in the protocol C) This subject only needs to undergo the study procedures that pertain specifically to the subject D) This subject can undergo the study procedures whenever it is convenient - CORRECT ANSWER-B) This subject should undergo all study procedures as outlined in the protocol A purpose of monitoring clinical trials is to verify that: A) The rights, safety, and well-being of human subjects are protected B) Investigators receive adequate payment for their participation in the clinical trial C) The investigator has received annual reports from the sponsor D) The regulatory agency has received all case history information of subjects enrolled on the clinical trial - CORRECT ANSWER-A) The rights, safety, and well-being of human subjects are protected Which of the following is the proper way to make a correction to a CRF? A) Completely blacken the incorrect entry and then enter the correct information B) Back date the corrected entry with the date of the original entry C) Initial using the initials of the sponsor's representative who reviewed the change This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - CORRECT ANSWER-C) 3500 Reminder: 3500 is for voluntary; 3500A is for mandatory Each IRB that reviews studies involving children as subjects is covered by: A) 21CFR Part 56, Sub part A B) 21CFR Part 56, Sub part B C) 21CFR Part 50, Sub part C D) 21CFR Part 56, Sub part D - CORRECT ANSWER-D) 21CFR Part 56, Sub part D This form is used for the mandatory reporting of serious adverse events: A) 1571 B) 1572 C) 3500 D) 3500A - CORRECT ANSWER-D) 3500A What is covered in 21CFR50 Subpart B? A) Informed consent of Human Subjects B) IRB Functions and Operations C) Records and Reports D) Additional Safeguards for Children in Clinical Investigations - CORRECT ANSWER- A) Informed consent of Human Subjects True or False: The IRB must determine that requirements for permission by parents or guardians and assent by children are met. - CORRECT ANSWER-True Explanation: According to 45 CFR 46 and 21 CFR 50.55 What topic is covered in 45 CFR 46 Subpart B? A) Additional Safeguards and Protections B) Additional Protection for Prisoners and Vulnerable Subjects C) Additional Protection for Children and Unborn Fetuses D) None of the above - CORRECT ANSWER-D) None of the above The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion. A) 6 months B) 1 year C) 2 years D) 5 years - CORRECT ANSWER-B) 1 Year The 3 fundamental ethical principles for human subjects' in research are: A) Respect for persons, beneficence, justice B) Respect for subjects, their safety and their time C) Respect for sponsor, IRB and FDA guidelines D) Respect for data, welfare and discovery - CORRECT ANSWER-A) Respect for persons, beneficence, justice Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________. A) 45 CFR 46.110; CFR 56.110(c) B) 45 CFR 46.110(c); 21 CFR 56.110 C) 45 CFR 46.110(c); 21 CFR 56.110(c) D) 45 CFR 46.110(b); 21 CFR 56.110(c) - CORRECT ANSWER-C) 45 CFR 46.110(c); 21 CFR 56.110(c) Explanation: Section B3 In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________. A) expected B) serious C) would have implications for the conduct of the study D) B & C E) A, B & C - CORRECT ANSWER-D) B & C B - serious C - would have implications for the conduct of the study Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study. A) 24 hours B) 48 hours C) 3 WD D) 5 WD - CORRECT ANSWER-B) 5 working days True or False: A Short Form informed consent is a written summary of the ICF that is not to exceed one page. - CORRECT ANSWER-False Explanation: 21 CFR 50.27 Identify the manner in which the informed consent form (ICF) can be presented to the subject A) ICF can be read to the subject of the LAR B) ICF is handed to the subject to read and sign on their own in private C) ICF is delivered via FedEx with a return stamped envelope D) ICF must be delivered to the subject or LAR electronically with a read receipt requested - CORRECT ANSWER-A) ICF can be read to the subject of the LAR True or False: When using the short form informed consent, the witness and the person actually obtaining the consent from the subject shall each sign the short form in addition to the summary. - CORRECT ANSWER-False Explanation: 21 CFR 50.27 (2) The witness shall sign both the short form and summary. Person actually obtaining consent shall sign only a copy of the summary. Subject only has to sign the short form). True or False: Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. - CORRECT ANSWER-True Explanation: 21 CFR 312.32(c)(1) FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review. - CORRECT ANSWER-True Explanation: 21 CFR 56.105 (Waiver of IRB Requirement) True or False: The Code of Federal Regulations part 50, 56 and 312 (among others) are designed to ensure the safety of clinical testing and the safety of products following a marketing approval. - CORRECT ANSWER-True Explanation: 21 CFR 312.88 The Food and Drug Administration (FDA) conducts drug risk assessment by considering which of the following? A) There are a sufficient number of people needing the drug. B) The benefits of the drug outweigh the known and potential risk of the drug C) The side-effects of the drug is measurable D) The sponsor is able to financially support the research - CORRECT ANSWER-B) The benefits of the drug outweigh the known and potential risk of the drug An investigational drug can be exported from the U.S., if: A) Permission is granted by Congress B) The intended recipient is a US pharmacy C) The importer is a foreign pharmacy inspected and approved by the FDA D) Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner. E) The drug is for investigational use only and goes directly to a potential patient - CORRECT ANSWER-D) Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner. True or False: Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days. - CORRECT ANSWER-False Explanation: Within 5 working days; 21 CFR 56.104(c) True or False: A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing investigations. - CORRECT ANSWER-False Explanation: A Clinical Hold is an order by FDA to the sponsor (not investigator) to suspend or stop ongoing investigations. True or False: An IND is always required before using an investigational new drug. - CORRECT ANSWER-False Explanation: Allows for emergency use; 21 CFR 312.36