Test Your Knowledge About SOCRA

62 Questions | Total Attempts: 590

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SOCRA Quizzes & Trivia

Questions and Answers
  • 1. 
    What are the three fundamental ethical principals for human subjects research?
    • A. 

      Autonomy of Patients

    • B. 

      Respect for Persons

    • C. 

      Informed Consent for Participation in Research

    • D. 

      Beneficence

    • E. 

      Justice

    • F. 

      Fair Distribution of Cost/Benefit Ratio

    • G. 

      Non-Exploitative and Well-Considered procedures

    • H. 

      Maximizing Benefits, Minimizing Risks

  • 2. 
    The FDA form 483 is used for ...
  • 3. 
    What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?
    • A. 

      CRO - Clinical Research Organization

    • B. 

      CRO - Contracted Research Organization

    • C. 

      CRO - Center for Research Operations

    • D. 

      CRO - Contracted Research Operations

  • 4. 
    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 Practice (GCP)

    • C. 

      The Declaration of Helsinki

    • D. 

      Fundamental Ethical Principles (FEP)

  • 5. 
    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

  • 6. 
    The Code of Federal Regulations that applies to Investigational New Drug Applications is..
    • A. 

      21CFR11

    • B. 

      21CFR812

    • C. 

      45CFR46

    • D. 

      21CFR312

  • 7. 
    The object of GCP is part of the ICH mission statement.
    • A. 

      True

    • B. 

      False

  • 8. 
    What is the minimum number of IRB members?
    • A. 

      2

    • B. 

      10

    • C. 

      15

    • D. 

      5

  • 9. 
    Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...
    • A. 

      Mission statement of the ICH

    • B. 

      Mission statement of the GCP Guidelines

    • C. 

      Mission statement of the Declaration of Helsinki

    • D. 

      Mission statement of Canada Health

  • 10. 
    The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
    • A. 

      21CFR11

    • B. 

      21CFR812

    • C. 

      21CFR312

    • D. 

      21CFR56

  • 11. 
    What is the federal department responsible for helping people of Canada maintain and improve their health?
    • A. 

      Federal Department of Food and Drug Administration

    • B. 

      Canada Health

    • C. 

      Health Canada

    • D. 

      Federal Department of Canadian Health and Safety

  • 12. 
    The Code of Federal Regulations that applies to the Protection of Human Subjects is..
    • A. 

      21CFR11

    • B. 

      45CFR46

    • C. 

      21CFR812

    • D. 

      21CFR312

  • 13. 
    Who monitors the progress of all clinical trial investigations being conducted under its IND?
    • A. 

      The Principle Investigator

    • B. 

      The Institutional Review Board

    • C. 

      The Sponsor

    • D. 

      The CRO

  • 14. 
    A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
  • 15. 
    What is the FDA form 482 for?
    • A. 

      Notice of Inspection

    • B. 

      Findings of Inspection

    • C. 

      Declaration of Financial Interests and Arrangements

    • D. 

      Certification of Financial Interests and Arrangments

  • 16. 
    The Code of Federal Regulations that applies to Institutional Review Boards is..
    • A. 

      45CFR46

    • B. 

      21CFR312

    • C. 

      21CFR56

    • D. 

      21CFR50

  • 17. 
    A(n) ___________________ can be any unfavorable and unintended sign )including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 
  • 18. 
    In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.
  • 19. 
    The "Doctor's Trial" prompted the Bellmont Report.
    • A. 

      True

    • B. 

      False

  • 20. 
    A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.
  • 21. 
    A significant risk device....
    • A. 

      Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.

    • B. 

      Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.

    • C. 

      For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.

  • 22. 
    The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....
    • A. 

      The Bellmont Report

    • B. 

      The National Research Act

    • C. 

      The International Research Act

    • D. 

      The Declaration of Helsinki

  • 23. 
    ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
  • 24. 
    The form _____________ is used for investigational new drugs (or IND).
  • 25. 
    Under 21CFR312, this form is the statement of the investigator of a clinical trial
    • A. 

      1572

    • B. 

      1571

    • C. 

      3454

    • D. 

      483

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