Vigilance Assessment

7 Questions | Attempts: 105
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  • 1/7 Questions

    When i come across an AE, i would

    • Complete form 11330
    • Inform my Manager and Local subsidiary Communications team
    • Withold the information
    • Both a & b
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  • 2. 

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

    • Pateint

    • Reporter

    • Product

    • All of the above

    Correct Answer
    A. All of the above
  • 3. 

    Vigilance is;

    • A Must Do for everyone

    • Good to for everyone

    • Not compulsory for everyone

    • Not my responsibility

    Correct Answer
    A. A Must Do for everyone
  • 4. 

    AE is potentially serious if it results in any one of the following outcomes;

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

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

    • Requires intervention to prevent one of the above

    • All of the above

    Correct Answer
    A. All of the above
  • 5. 

    As per SOP 8920, Non Serious AEs are to be reported within;

    • 1 day of occurence

    • 2 days of occurence

    • 7 days of occurence

    • 1 month of occurence

    Correct Answer
    A. 7 days of occurence
  • 6. 

    As per SOP 8920, Potential Serious AEs are to be reported within;

    • 1 day of occurence

    • 2 days of occurence

    • 1 week of occurence

    • 1 month of occurence

    Correct Answer
    A. 1 day of occurence
  • 7. 

    An Adverse event;

    • Is a untoward medical occurrence

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

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

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    An AE is any untoward medical occurrence in a patient administered a medicinal product or in a consumer having used or using a C-P product and which does not necessarily have to have a causal relationship with this treatment or use

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Quiz Review Timeline (Updated): Mar 26, 2013 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Mar 26, 2013
    Quiz Edited by
    ProProfs Editorial Team
  • Mar 26, 2013
    Quiz Created by
    Mukundkamath
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