Investigational Product Management Flashcards
7 cards from real SOCRA CCRP 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
Who is primarily responsible for maintaining investigational product accountability records at a clinical trial site?
Answer: The principal investigator or designee
Under ICH GCP E6(R2), the principal investigator or their designee is responsible for maintaining accurate IP accountability records at the site.
According to ICH GCP E6(R2), investigational products must be stored under conditions specified by:
Answer: The sponsor's protocol and investigational product information
ICH GCP requires IP to be stored according to conditions specified by the sponsor in the protocol or in the IP information provided to the site.
What document is used at a clinical trial site to track all dispensing, administration, and returns of investigational product?
Answer: Investigational Product Accountability Log
The IP Accountability Log records all transactions involving investigational product, including receipt, dispensing, administration, and return or destruction.
When an investigational product shipment is received at a clinical site, what is the FIRST action the site should take?
Answer: Inspect and document the shipment against the packing slip and protocol requirements
Upon receipt, the site must inspect the shipment for condition, quantity, and storage compliance and document findings against the packing slip.
A temperature excursion is detected in the IP storage refrigerator over a weekend. What is the appropriate FIRST action?
Answer: Quarantine the affected IP and notify the sponsor
Affected IP must be quarantined and the sponsor notified so the sponsor can assess whether the product remains suitable for use.
At study close-out, what typically happens to unused investigational product?
Answer: It is returned to the sponsor or destroyed per sponsor instructions with full documentation
Unused IP must be returned to the sponsor or destroyed per sponsor instructions, with all transactions documented in the accountability log.
Which of the following best describes 'blinded' investigational product in a randomized controlled trial?
Answer: IP where the identity of active drug versus placebo is concealed from participants and/or investigators
In blinded trials, the identity of the investigational product (active versus placebo) is concealed to reduce bias in the conduct and evaluation of the trial.