Investigational Product Management Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigational Product Management flashcards as text
What is an 'emergency code break' in the context of a blinded clinical trial?
Answer: Unblinding a subject's treatment assignment for medical management
An emergency code break is the formal process of revealing a blinded subject's treatment assignment when it is medically necessary for the care of that subject.
How must unused investigational product typically be handled at study close-out?
Answer: Returned to the sponsor or destroyed per sponsor instructions with full documentation
Unused investigational product must be returned to the sponsor or destroyed per sponsor-approved procedures, with complete documentation of all dispositions.
What is the primary purpose of a kit number or bottle number on investigational product in a blinded study?
Answer: To uniquely identify and track each unit of IP while maintaining blinding
Kit and bottle numbers uniquely identify each unit of investigational product, enabling full accountability and tracking without revealing the treatment assignment in blinded studies.
Which US regulation establishes requirements for investigational drug storage, handling, and accountability at clinical trial sites?
Answer: 21 CFR Part 312
21 CFR Part 312, which governs Investigational New Drug applications, establishes the US regulatory requirements for investigational drug storage, handling, and accountability.
What should a site do upon receiving investigational product with visibly damaged or compromised packaging?
Answer: Document the damage, quarantine the product, and notify the sponsor
Damaged product must be quarantined to prevent its use, the damage documented, and the sponsor notified so they can assess product integrity before any decision is made.
Per 21 CFR Part 312, what is the minimum retention period for drug accountability records after a study is completed?
Answer: 2 years after marketing approval or 2 years after the IND is discontinued
Per 21 CFR 312.62, drug accountability records must be retained for 2 years after marketing approval of the drug or 2 years after the IND is discontinued.
Who is authorized to dispense investigational product to study subjects at a clinical trial site?
Answer: Only authorized pharmacy or designated licensed personnel per site SOPs and protocol
Dispensing of investigational product must be performed only by formally authorized personnel, typically a licensed pharmacist or designee, as specified in site SOPs and the protocol.