ACRP Investigational Product Management Flashcards

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

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

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

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

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

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

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

Answer: Full accountability for both active and placebo treatments must be maintained

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

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

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

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

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

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

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

How long must investigational product accountability records be retained after the completion of a clinical trial in the US?

Answer: 2 years after the study ends or after NDA/BLA approval, whichever is longer

Per 21 CFR 312.62, IP accountability records must be retained for 2 years after study completion or NDA/BLA approval, whichever is later.