ACRP Investigational Product Management Flashcards

What is an Investigational New Drug (IND) application and who submits it?

Answer: A FDA submission by the sponsor authorizing the use of an investigational drug in human trials

An IND application is submitted by the sponsor to the FDA to obtain authorization to administer an unapproved investigational drug to human subjects.

What does 'double-blind' mean in the context of investigational product dispensing?

Answer: Neither the participant nor the investigator knows the treatment assignment

In a double-blind trial, neither the participant nor the investigator knows whether the participant is receiving active drug or placebo, reducing bias.

Which of the following is a key component of the investigational product reconciliation process?

Answer: Matching IP shipped, dispensed, and returned/destroyed quantities to account for all units

Reconciliation verifies that all IP units shipped to the site are accounted for through dispensing records, returns, and destruction documentation.

What is a 'comparator' drug in a clinical trial?

Answer: An approved or investigational drug used as a control against the study drug

A comparator drug is an active treatment (approved or investigational) used as a reference in controlled trials to benchmark the investigational product.

What is the significance of a 'lot number' on investigational product packaging?

Answer: It allows traceability of the specific manufacturing batch for quality control and recall purposes

Lot numbers enable manufacturers and sponsors to trace any IP unit back to its production batch, facilitating quality investigations and recalls.

Under 21 CFR Part 312, which party is responsible for ensuring adequate IP supplies are available for a clinical trial?

Answer: The Sponsor

Per 21 CFR 312.61, the sponsor is responsible for supplying investigators with adequate quantities of IP to conduct the clinical trial.