Good Clinical Practice (GCP)

5 Questions | Total Attempts: 2492

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Good Clinical Practice (GCP)

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Questions and Answers
  • 1. 
    According to the principles of ICH GCP, what is the most important consideration when conducting a clinical trial?
    • A. 

      Data accuracy

    • B. 

      Protection of trial subjects

    • C. 

      Protocol adherence

    • D. 

      Statistical quality checks

  • 2. 
    Which of these is NOT a category of adverse event classification as serious?
    • A. 

      Permenent or significant incapacity

    • B. 

      Hospitalization

    • C. 

      Congenital anomaly

    • D. 

      Life-threatening

    • E. 

      Data inaccuracy

  • 3. 
    The investigator's opinion of relationship between an observed adverse event and a test article does NOT determine whether an event must be reported to the sponsor.
    • A. 

      True

    • B. 

      False

  • 4. 
    According to ICH GCP, the sponsor should obtain the investigator's agreement to...?
    • A. 

      To conduct the trial in accordance with GCP and applicable regulatory requirements

    • B. 

      To comply with procedures for data recording/reporting

    • C. 

      To permit monitoring

    • D. 

      All of the above

  • 5. 
    A no greater than minimal risk protocol includes research on females, ages 12 to 55.  A pregnant female, age 17, wants to participate in the research study.  The study would benefit both the pregnant female and the fetus.  Who must provide consent (check all that apply)?
    • A. 

      Pregnant female

    • B. 

      Fetus' paternal father

    • C. 

      Pregnant female's surrogate

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