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CCRP SOCRA Exam Practice Exam #1 With Answers 2025.pdf, Exams of Nursing

CCRP SOCRA Exam Practice Exam #1 With Answers 2025.pdf

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CCRP SOCRA Exam Practice Exam #1 With Answers 2023
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
C) Sponsor
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10
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
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
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CCRP SOCRA Exam Practice Exam #1 With Answers 2023 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 C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 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 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

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 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 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

True or False: When a short form is used for Informed Consent, the witness must sign either the short form or the summary. False Why: They must sign both Form___________ is the investigator statement. A) 1571 B) 1572 C) 3500 D) 3500A B) 1572 What is 45 CFR Part 46? A) HHS - Protection of Human Subjects B) FDA - Protection of Human Subjects C) HHS - Protection of Children D) HHS - Protection of Research Participants A) HHS - Protection of Human Subjects Explanation: 45 CFR Part 46 covers the HHS (Health and Human Services) standards of protection of human subjects. Also referred to as Public Welfare. True or False: The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812. False INDs are covered in 21 CFR 312 Who monitors the progress of all clinical trial investigations being conducted under an IND? A) Principal Investigator B) IRB C) Sponsor D) CRO C) Sponsor

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called: A) The Belmont Report B) The National Research Act C) The Nuremberg Code D) The Declaration of Helsinki D) The Declaration of Helsinki The Code of Federal Regulations that applies to Institutional Review Boards is: A) 45CFR B) 21CFR C) 21CFR D) 21CFR D) 21 CFR 56 The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as: A) The ICH B) Good Clinical Practices (GCP) C) The Declaration of Helsinki D) Fundamental Ethical Principles (FEP) B) Good Clinical Practices (GCP) This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A 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 D) 21CFR Part 56, Sub part D

C) Respect for sponsor, IRB and FDA guidelines D) Respect for data, welfare and discovery 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. C) 45 CFR 46.110(c); 21 CFR 56.110(c) D) 45 CFR 46.110(b); 21 CFR 56.110(c) C) 45 CFR 46.110(c); 21 CFR 56.110(c) Explanation: Section B 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 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 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.

False Explanation: 21 CFR 50. 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 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. 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. True Explanation: 21 CFR 312.32(c)(1) During the clinical trial, regulations require that a subject be given the right to: A) Travel

B) Financial hardship C) Concern D) Injury, disability or death D) Injury, disability or death Explanation: Nuremburg Code (#7) True or False: After completion of the investigation, sponsor shall provide the investigator with a final report. False Explanation: An investigator shall provide the sponsor with a final report Per 21 CFR Part 312, who is required to sign a 1572 Statement of Investigator form? A) The investigator B) The coordinator C) The investigator and the coordinator D) Anyone substantially involved in the study A) The investigator Explanation: 21 CFR 312.53(1) A request to export an investigational drug from the U.S. must include: A) The quantity of drug to be shipped per shipment and the frequency of expected shipments. B) Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals. C) A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use. D) All of the above E) A & C only E) A & C only A) The quantity of drug to be shipped per shipment and the frequency of expected shipments.

C) A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use. True or False: FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review. 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. True Explanation: 21 CFR 312. 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 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