CRAP Post-Market Surveillance & Vigilance Flashcards
6 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRAP Post-Market Surveillance & Vigilance flashcards as text
How does the Sentinel Initiative complement traditional passive surveillance systems like FAERS?
Answer: It conducts active surveillance by querying distributed electronic health records
Sentinel complements FAERS by actively querying distributed electronic health data networks to detect safety signals rather than relying solely on voluntary spontaneous reports.
Which of the following best describes a corrective action within a CAPA (Corrective and Preventive Action) system?
Answer: Investigating a root cause of nonconformance and implementing fixes to prevent recurrence
A corrective action addresses an identified nonconformance by determining its root cause and implementing process changes to prevent the problem from recurring.
Under 21 CFR Part 7, how is a Class I recall defined?
Answer: A situation where use or exposure to the product will cause serious adverse health consequences or death
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.
What is a 'field safety corrective action' (FSCA) in the context of medical devices?
Answer: Any action to reduce a risk of death or serious injury associated with an already-distributed device
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.
What must a Periodic Adverse Drug Experience Report (PADER) include for an NDA holder?
Answer: A summary of all adverse drug experiences received during the reporting period
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.
What is the purpose of FDA's Expanded Access (compassionate use) program?
Answer: It provides patients with serious conditions access to investigational products outside clinical trials
The Expanded Access program allows patients with serious or life-threatening conditions to access investigational drugs or devices when no comparable alternatives exist and enrollment in a clinical trial is not feasible.