Investigational Product Management & Drug Accountability Flashcards
7 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 7 Investigational Product Management & Drug Accountability flashcards as text
In a double-blind randomized controlled trial, an emergency unblinding for a single subject is medically necessary. What is the correct procedure?
Answer: Follow the sponsor's emergency unblinding procedure, notify the sponsor promptly, and document the reason and outcome
Emergency unblinding must follow the sponsor's pre-defined procedure, be limited to the affected subject, and be documented with immediate notification to the sponsor to preserve trial integrity for other subjects.
What is a drug reconciliation discrepancy?
Answer: A mismatch between the quantity of investigational product received, dispensed, returned, and destroyed
A drug reconciliation discrepancy occurs when the arithmetic sum of product received minus product dispensed minus product returned/destroyed does not equal zero, indicating an unexplained quantity.
How long must drug accountability records typically be retained after study completion under FDA regulations?
Answer: 2 years after the study is approved or discontinued, or 2 years after the investigational drug is marketed
Under 21 CFR 312.62, investigators must retain records for 2 years after a marketing application is approved or, if no application is filed, 2 years after the investigation is discontinued and FDA is notified.
A subject returns 4 of 10 dispensed tablets at the next visit. The diary shows 5 doses taken. What should the site do?
Answer: Document the discrepancy, query the subject about the missing tablet, and record the explanation in the accountability log
A count mismatch (10 dispensed − 5 taken = 5 expected returns, but only 4 returned) requires site staff to query the subject, document the explanation, and record everything in the accountability log to resolve the discrepancy.
Which of the following best describes 'blinded drug kits' used in a double-blind trial?
Answer: Packages where both active drug and placebo are made identical in appearance, smell, and labeling to conceal treatment assignment
Blinded drug kits are manufactured so that active drug and placebo are indistinguishable to both the subject and site staff, preserving the blind and preventing bias in outcome assessment.
What is the role of a sponsor's Clinical Research Associate (CRA) during a drug accountability monitoring visit?
Answer: To verify that IP records are complete, accurate, and that physical inventory matches the accountability log
During monitoring visits, the CRA reviews drug accountability records and performs a physical count of IP to verify that quantities on hand match what the log indicates should be remaining.
An investigational product label for a US Phase II trial must include which of the following statements?
Answer: "Caution: New Drug—Limited by Federal Law to Investigational Use"
Per 21 CFR 312.6, investigational drug labels must bear the statement 'Caution: New Drug—Limited by Federal (or United States) law to investigational use' to clearly identify its investigational status.