CRAP CRAP Post-Market Surveillance & Vigilance 3

Question 1

How does the Sentinel Initiative complement traditional passive surveillance systems like FAERS?

Accepted Answer

It conducts active surveillance by querying distributed electronic health records

Answer

Sentinel complements FAERS by actively querying distributed electronic health data networks to detect safety signals rather than relying solely on voluntary spontaneous reports.

Question 2

Which of the following best describes a corrective action within a CAPA (Corrective and Preventive Action) system?

Accepted Answer

Investigating a root cause of nonconformance and implementing fixes to prevent recurrence

Answer

A corrective action addresses an identified nonconformance by determining its root cause and implementing process changes to prevent the problem from recurring.

Question 3

Under 21 CFR Part 7, how is a Class I recall defined?

Accepted Answer

A situation where use or exposure to the product will cause serious adverse health consequences or death

Answer

A Class I recall is the most serious type, involving products where use or exposure is reasonably likely to cause serious adverse health consequences or death.

Question 4

What is a 'field safety corrective action' (FSCA) in the context of medical devices?

Accepted Answer

Any action to reduce a risk of death or serious injury associated with an already-distributed device

Answer

An FSCA is any action taken by a manufacturer or distributor to reduce the risk of death or serious health deterioration associated with a device already placed on the market.

Question 5

What must a Periodic Adverse Drug Experience Report (PADER) include for an NDA holder?

Accepted Answer

A summary of all adverse drug experiences received during the reporting period

Answer

PADERs require NDA holders to submit quarterly and annual summaries of all adverse drug experiences received during the reporting period, including domestic and foreign reports.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP CRAP Post-Market Surveillance & Vigilance 3