ACRP ACRP Investigational Product Management 1

Question 1

Who is primarily responsible for maintaining the investigational product accountability records at a clinical trial site?

Accepted Answer

The Principal Investigator

Answer

The Principal Investigator is ultimately responsible for IP accountability, including storage, dispensing, and return logs per FDA regulations.

Question 2

What document must be completed each time investigational product is dispensed to a study participant?

Accepted Answer

Drug Accountability Log

Answer

A Drug Accountability Log records each dispensing event, including lot numbers, amounts dispensed, and participant identifiers.

Question 3

Under what conditions must investigational product be stored at a clinical trial site?

Accepted Answer

Per sponsor protocol and applicable regulations

Answer

IP must be stored according to sponsor-specified conditions (temperature, humidity, light) and applicable 21 CFR regulations.

Question 4

What is the purpose of a certificate of analysis (CoA) for investigational product?

Accepted Answer

To document IP quality, identity, and potency

Answer

A CoA certifies that the IP batch meets specified quality standards and confirms identity, potency, purity, and safety.

Question 5

What action must be taken with unused investigational product at the end of a clinical trial?

Accepted Answer

Return or destroy per sponsor instructions and document appropriately

Answer

Unused IP must be returned to the sponsor or destroyed per protocol-specified procedures, with full documentation of the disposition.

ACRP - Association of Clinical Research Professionals Practice Test