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Reporting Safety Information and Product Quality Complaints
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1
What is an AE?
An AE is any untoward medical occurrence in a patient or clinical investigation subject who has been administered a pharmaceutical product and which does not necessarily require a causal relationship with this treatment.
An AE can be any unfavorable or unintended sign (for example, an abnormal laboratory finding), symptom, or disease that is temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
All of the above
None of the above
2
What is the timeframe for reporting safety information and PQCs?
Report within a week
Report within one business day.
Report as soon as you get a minute.
Report promptly, but not to exceed the lesser of one business day or three calendar days.
3
AEs should be collected and reported regardless of whether the products are referred by its brand or generic name. Is the above statement true or false?
True
False
4
Which of the following special situations should be reported in the same way as any AE?
Drug abuse
Misuse
LOE
Occupational exposure
Medication error and potential medical error
Suspected transmission of an infectious agent
Overdose
Suspected drug interaction
All of the above
None of the above
5
Pregnancy-related information includes all reports of elevated/questionable, indeterminate β hCGs, or positive urine pregnancy tests after administration of a product. Is the above statement true or false?
True
False
6
Which of the following minimum information are required to promptly report safety information?
Wybierz jedną odpowiedź
Reporter information
Patient information
Event information associated with the product
Product information
All of the above
None of the above
7
All special situations, even if not associated with an AE, need to be reported. Is the above statement true or false?
Wybierz jedną odpowiedź
True
False
8
For which of the following instances would you report a PQC?
Wybierz jedną odpowiedź
A device needle remained exposed upon administration.
A label on the bottle was missing an expiry date.
A black particle was found in the reconstituted product.
A blister pack was hard to open.
All of the above
None of the above
9
Which of the following information should you collect to report a safety information?
As much information as possible
Name and contact details of the person reporting the safety information
Drug name
Lot number and batch number
Patient demographics
Dosage information
All of the above
None of the above
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