ACRP Investigational Product Management Flashcards
6 cards from real ACRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 ACRP Investigational Product Management flashcards as text
Who is primarily responsible for maintaining the investigational product accountability records at a clinical trial site?
Answer: The Principal Investigator
The Principal Investigator is ultimately responsible for IP accountability, including storage, dispensing, and return logs per FDA regulations.
What document must be completed each time investigational product is dispensed to a study participant?
Answer: Drug Accountability Log
A Drug Accountability Log records each dispensing event, including lot numbers, amounts dispensed, and participant identifiers.
Under what conditions must investigational product be stored at a clinical trial site?
Answer: Per sponsor protocol and applicable regulations
IP must be stored according to sponsor-specified conditions (temperature, humidity, light) and applicable 21 CFR regulations.
What is the purpose of a certificate of analysis (CoA) for investigational product?
Answer: To document IP quality, identity, and potency
A CoA certifies that the IP batch meets specified quality standards and confirms identity, potency, purity, and safety.
What action must be taken with unused investigational product at the end of a clinical trial?
Answer: Return or destroy per sponsor instructions and document appropriately
Unused IP must be returned to the sponsor or destroyed per protocol-specified procedures, with full documentation of the disposition.
Which temperature monitoring practice is required for investigational products requiring refrigeration?
Answer: Use calibrated continuous monitoring with excursion documentation
Continuous, calibrated temperature monitoring with documentation of any excursions ensures IP integrity throughout the trial.
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