SOCRA CCRP Practice Exam #1

50 Questions | Total Attempts: 1746

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SOCRA CCRP Practice Exam #1 - Quiz

Tests on classes 1-7 material including: - Ethics - 21 CFR Parts 50, 56, 312 and 812 - 45 CFR Part 46 *directly from SOCRA


Questions and Answers
  • 1. 
    *The responsibility for ensuring that the investigator understands a clinical trial lies with:
    • A. 

      FDA

    • B. 

      IRB

    • C. 

      Sponsor 

    • D. 

      Coordinator 

  • 2. 
    *What is the minimum number of IRB members?
    • A. 

      3

    • B. 

      5

    • C. 

      6

    • D. 

      10

  • 3. 
    *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

  • 4. 
    *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

  • 5. 
    *In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled 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 

  • 6. 
    *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

  • 7. 
    *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

  • 8. 
    *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

    • D. 

      Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

  • 9. 
    The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
    • A. 

      True

    • B. 

      False

  • 10. 
    The contents of a Protocol should generally contain:
    • A. 

      Trial objectives and purpose

    • B. 

      Assessment of efficacy

    • C. 

      Data handling and record keeping

    • D. 

      All of the above 

    • E. 

      Only A & C

  • 11. 
    Only the principle investigator is allowed to transcribe data from the source document to the CRF? 
    • A. 

      True

    • B. 

      False

  • 12. 
    When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
    • A. 

      True

    • B. 

      False

  • 13. 
    Form___________ is the investigator statement.
    • A. 

      1571

    • B. 

      1572

    • C. 

      3500

    • D. 

      3500A

  • 14. 
    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 

  • 15. 
    The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812.
    • A. 

      True

    • B. 

      False

  • 16. 
    Who monitors the progress of all clinical trial investigations being conducted under an IND?
    • A. 

      Principal Investigator

    • B. 

      IRB

    • C. 

      Sponsor

    • D. 

      CRO

  • 17. 
    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 

  • 18. 
    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)

  • 19. 
    The Code of Federal Regulations that applies to Institutional Review Boards is:
    • A. 

      45CFR46

    • B. 

      21CFR312

    • C. 

      21CFR50

    • D. 

      21CFR56

  • 20. 
    This form is used for the voluntary reporting of adverse events and product problems: 
    • A. 

      1571

    • B. 

      1572

    • C. 

      3500

    • D. 

      3500A

  • 21. 
    *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

  • 22. 
    This form is used for the mandatory reporting of serious adverse events:
    • A. 

      1571

    • B. 

      1572

    • C. 

      3500

    • D. 

      3500A

  • 23. 
    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 

  • 24. 
    *The IRB must determine that requirements for permission by parents or guardians and assent by children are met.
    • A. 

      True

    • B. 

      False

  • 25. 
    What topic is covered in 45CFR46 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