CPI Clinical Site Operations & Investigational Product Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Clinical Site Operations & Investigational Product flashcards as text
What is an Investigational New Drug (IND) application, and who submits it?
Answer: An application submitted to the FDA by a sponsor to authorize shipment and use of an unapproved drug in clinical trials
An IND is filed with the FDA by the sponsor to authorize clinical trials involving an investigational drug that has not yet received marketing approval.
What is the correct procedure when a site receives a shipment of investigational product (IP)?
Answer: Verify the shipment against the packing slip, check integrity and storage conditions, log receipt in the IP accountability log
Upon receipt, site staff must verify the shipment, inspect for damage or temperature excursions, and document receipt in the investigational product accountability log.
A study participant accidentally receives the wrong dose of investigational product. What is the PI's first priority?
Answer: Ensure the participant's safety and medical wellbeing, then document and report the error
Participant safety is always the first priority; the PI must assess and address any safety concerns immediately, then document and report the medication error.
What is required when investigational product that is unused or expired must be disposed of at a clinical site?
Answer: Follow the sponsor's IP return/destruction instructions and document disposition in the accountability log
Unused or expired IP must be disposed of per the sponsor's instructions, with every unit accounted for and destruction documented in the IP accountability log.
What does 'randomization' mean in a clinical trial and why is maintaining the blind important?
Answer: Random assignment of participants to treatment groups to minimize bias, and blinding prevents knowledge of assignment from influencing outcomes
Randomization reduces selection bias by randomly assigning participants to treatment arms, and blinding prevents foreknowledge of assignments from influencing behavior or data collection.
Under what circumstance is emergency unblinding of a participant's treatment assignment permissible in a blinded clinical trial?
Answer: When knowledge of the assignment is essential for the safe medical management of the participant
Emergency unblinding is only permissible when a participant's treatment assignment must be known to provide safe and appropriate medical care, and the event must be documented and reported.