CPI Investigational Product Management & Drug Accountability

Question 1

What is the primary purpose of maintaining drug accountability records in a clinical trial?

Accepted Answer

To ensure investigational product is used only as specified in the protocol and accounted for throughout the trial

Answer

Drug accountability records ensure that investigational products are dispensed, used, and returned or destroyed as specified by the protocol, maintaining trial integrity and regulatory compliance.

Question 2

According to FDA regulations, who at the investigational site bears primary responsibility for investigational product accountability?

Accepted Answer

The principal investigator

Answer

Under 21 CFR Part 312, the principal investigator is ultimately responsible for ensuring investigational product is used only for subjects under their supervision and that accountability records are maintained.

Question 3

Which of the following must be documented each time an investigational product is dispensed to a study subject?

Accepted Answer

Date, quantity dispensed, lot number, expiration date, and subject identifier

Answer

Dispensing records must capture date, quantity, lot number, expiration date, and subject identifier to create a complete chain of custody and enable reconciliation.

Question 4

What action is required when a shipment of investigational product arrives at the clinical site?

Accepted Answer

Inspect shipment, verify contents against shipping manifest, and document receipt in accountability log

Answer

Upon receipt, site staff must inspect the shipment for damage, verify contents against the shipping manifest, check storage conditions during transit, and document the receipt in the drug accountability log.

Question 5

A refrigerated investigational product requires storage at 2°C–8°C. The site refrigerator log shows a temperature excursion to 12°C for 4 hours. What is the most appropriate immediate action?

Accepted Answer

Quarantine the affected product and notify the sponsor for disposition guidance

Answer

Temperature excursions require immediate quarantine of affected product and sponsor notification so the sponsor's quality team can evaluate stability data and provide disposition instructions.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Investigational Product Management & Drug Accountability