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

To track the cost of investigational products for billing purposes

Answer

To satisfy marketing requirements set by the pharmaceutical sponsor

Answer

To document adverse events related to investigational product use

Question 2

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

Accepted Answer

The principal investigator

Answer

The study coordinator

Answer

The sponsor's clinical research associate

Answer

The IRB pharmacist representative

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

Subject's insurance information and copay amount

Answer

Subject's social security number and emergency contact

Answer

Sponsor's manufacturing facility address and batch certificate

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

Immediately distribute to subjects to avoid storage fees

Answer

Return unopened to sponsor until IRB approval is confirmed

Answer

Repackage in study-blind containers before logging receipt

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

Discard the product immediately without notification

Answer

Continue dispensing since the excursion was brief

Answer

Re-cool the product and document the event in the next monitoring visit

Question 6

At study completion or early termination, what must happen to unused investigational product?

Accepted Answer

It must be returned to the sponsor or destroyed per sponsor instructions, with documentation

Answer

The investigator may keep it for compassionate use in non-study patients

Answer

It should be donated to a local pharmacy to reduce waste

Answer

It is automatically absorbed into the site's general drug inventory

Question 7

Which document provides the site with specific instructions for receiving, storing, dispensing, and returning investigational product?

Accepted Answer

The Pharmacy Manual or Investigational Product Management Plan

Answer

The IRB approval letter

Answer

The informed consent form

Answer

The Investigator's Brochure (IB)