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 document must be maintained at a clinical site to track the receipt, dispensing, and return or destruction of investigational product?
Answer: Drug Accountability Log
The Drug Accountability Log tracks all investigational product movements including receipt, dispensing to subjects, returns, and destruction to ensure complete accountability.
Which temperature range is defined as 'controlled room temperature' per USP standards for investigational product storage?
Answer: 15°C to 30°C
USP defines controlled room temperature as 15°C to 30°C (59°F to 86°F), which is the standard for products requiring room temperature storage.
Who bears ultimate responsibility for the proper use, storage, and accountability of investigational product at a clinical site?
Answer: The Principal Investigator
The Principal Investigator bears ultimate responsibility for all trial activities at the site, including proper handling and accountability of investigational product.
What should a CRA do upon discovering a temperature excursion in the investigational product storage area during a monitoring visit?
Answer: Document the excursion and notify the sponsor for product integrity assessment
Temperature excursions must be documented and reported to the sponsor, who will assess product integrity and provide guidance on whether the affected product can continue to be used.
In a double-blind clinical trial, what is the key requirement for investigational product labeling?
Answer: Labels must not reveal whether the product is active drug or placebo
Double-blind trial labeling must be coded so neither the subject nor the investigator can determine whether the product is active drug or placebo, preserving the blind.
Which document specifies the authorized dosing amount and schedule of investigational product to be dispensed to each subject?
Answer: The Clinical Protocol
The clinical protocol contains all dosing instructions, including the amount, frequency, and schedule of investigational product to be dispensed to study subjects.
During drug reconciliation, what accounting equation is the CRA verifying?
Answer: IP received = IP dispensed + IP on hand + IP returned or destroyed
Drug reconciliation confirms that IP received equals the sum of IP dispensed to subjects, IP remaining on hand, and IP returned or destroyed, ensuring complete accountability.