Vigilance Assessment
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- 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
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