ACRP ACRP Investigational Product Management 2

Question 1

What is an IP dispensing error and how should it be handled in a clinical trial?

Accepted Answer

An incorrect dose or product given; report and document immediately per protocol

Answer

Dispensing errors must be immediately documented and reported to the sponsor and possibly the IRB, as they may constitute protocol deviations.

Question 2

What information is typically required on an investigational product label per FDA regulations?

Accepted Answer

Protocol number, IND number, caution statement, storage conditions, and sponsor contact

Answer

FDA 21 CFR 312.6 requires IP labels to include a caution statement, protocol number, IND number, and storage conditions at minimum.

Question 3

When comparing a blinded investigational product to a placebo, which accountability principle still applies?

Accepted Answer

Full accountability for both active and placebo treatments must be maintained

Answer

All investigational products, including placebos, require complete accountability records regardless of blinding status.

Question 4

What is the role of a sponsor-designated pharmacist or designee in investigational product oversight?

Accepted Answer

To oversee IP storage, dispensing, and accountability at the site

Answer

A site pharmacist or qualified designee manages IP handling, including inventory control, dispensing records, and compliance with storage requirements.

Question 5

What should happen if the investigational product temperature excursion is discovered at a clinical trial site?

Accepted Answer

Document the excursion, quarantine the affected IP, and notify the sponsor immediately

Answer

Temperature excursions require immediate quarantine of affected IP, documentation, and sponsor notification to assess usability.

ACRP - Association of Clinical Research Professionals Practice Test

ACRP - Association of Clinical Research Professionals Practice Test

ACRP ACRP Investigational Product Management 2