Vigilance Assessment

1. 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

About This Quiz

What's your name? Personalize your quiz and earn a certificate with your name on it!

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

Pateint

Reporter

Product

All of the above

3. Vigilance is;

A Must Do for everyone

Good to for everyone

Not compulsory for everyone

Not my responsibility

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

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

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

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

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

Explanation

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