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

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

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