Vigilance Assessment

7 Questions

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Skill Assessment Quizzes & Trivia

Questions and Answers
  • 1. 
    An Adverse event;
    • A. 

      Is a untoward medical occurrence

    • B. 

      Can occur In a patient administered a medicinal product or in a consumer having used or using a C-P product

    • C. 

      Does not necessarily have to have a causal relationship with this treatment or use

    • D. 

      All of the above

  • 2. 
    AE is potentially serious if it results in any one of the following outcomes;
    • A. 

      Life- threatening incident needing medical intervention or even prolongs hospitalization / Death

    • B. 

      Persistent or significant disability / incapacity / Congenital anomaly / birth defect

    • C. 

      Requires intervention to prevent one of the above

    • D. 

      All of the above

  • 3. 
    As per SOP 8920, Potential Serious AEs are to be reported within;
    • A. 

      1 day of occurence

    • B. 

      2 days of occurence

    • C. 

      1 week of occurence

    • D. 

      1 month of occurence

  • 4. 
    As per SOP 8920, Non Serious AEs are to be reported within;
    • A. 

      1 day of occurence

    • B. 

      2 days of occurence

    • C. 

      7 days of occurence

    • D. 

      1 month of occurence

  • 5. 
    For it to qualify as an AE, apart from the experience, the other identifiable criteria are;
    • A. 

      Pateint

    • B. 

      Reporter

    • C. 

      Product

    • D. 

      All of the above

  • 6. 
    Vigilance is;
    • A. 

      A Must Do for everyone

    • B. 

      Good to for everyone

    • C. 

      Not compulsory for everyone

    • D. 

      Not my responsibility

  • 7. 
    When i come across an AE, i would
    • A. 

      Complete form 11330

    • B. 

      Inform my Manager and Local subsidiary Communications team

    • C. 

      Withold the information

    • D. 

      Both a & b