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

The principal investigator unilaterally decides the treatment assignment without documentation

Answer

Unblind the entire cohort to maintain consistency and fairness

Answer

Delay unblinding until the next scheduled Data Safety Monitoring Board meeting

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 difference between the approved protocol dose and the marketed dose of the drug

Answer

An error in the subject's medical history related to prior drug use

Answer

A disagreement between the investigator and sponsor about optimal dosing

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

1 year after the trial ends

Answer

Until the next FDA inspection, then they may be discarded

Answer

5 years after the last subject's last visit

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

Accept the return count and make no further inquiry

Answer

Report a serious adverse event for medication misuse

Answer

Discontinue the subject from the trial immediately

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

Drug kits that have been visually inspected and confirmed safe for dispensing

Answer

Kits stored in a locked cabinet visible only to the pharmacist

Answer

Drug containers that are sealed and cannot be opened until the subject is enrolled

Question 6

What is the role of a sponsor's Clinical Research Associate (CRA) during a drug accountability monitoring visit?

Accepted Answer

To verify that IP records are complete, accurate, and that physical inventory matches the accountability log

Answer

To dispense investigational product directly to enrolled subjects

Answer

To update the informed consent form based on new safety data

Answer

To randomize new subjects into the trial

Question 7

An investigational product label for a US Phase II trial must include which of the following statements?

Accepted Answer

"Caution: New Drug—Limited by Federal Law to Investigational Use"

Answer

"Approved by FDA for investigational use"

Answer

"For Clinical Trial Use Only—No Adverse Events Expected"

Answer

"Investigational Drug—Approved for Compassionate Use"