CPI Investigational Product Management & Drug Accountability 2

Question 1

In a double-blind randomized controlled trial, an emergency unblinding for a single subject is medically necessary. What is the correct procedure?

Accepted Answer

Follow the sponsor's emergency unblinding procedure, notify the sponsor promptly, and document the reason and outcome

Answer

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.

Question 2

What is a drug reconciliation discrepancy?

Accepted Answer

A mismatch between the quantity of investigational product received, dispensed, returned, and destroyed

Answer

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.

Question 3

How long must drug accountability records typically be retained after study completion under FDA regulations?

Accepted Answer

2 years after the study is approved or discontinued, or 2 years after the investigational drug is marketed

Answer

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.

Question 4

A subject returns 4 of 10 dispensed tablets at the next visit. The diary shows 5 doses taken. What should the site do?

Accepted Answer

Document the discrepancy, query the subject about the missing tablet, and record the explanation in the accountability log

Answer

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.

Question 5

Which of the following best describes 'blinded drug kits' used in a double-blind trial?

Accepted Answer

Packages where both active drug and placebo are made identical in appearance, smell, and labeling to conceal treatment assignment

Answer

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.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Investigational Product Management & Drug Accountability 2