ACRP ACRP Investigational Product Management

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 Clinical Research Coordinator

Answer

The Sponsor

Answer

The IRB

Question 2

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

Accepted Answer

Drug Accountability Log

Answer

Adverse Event Report

Answer

Informed Consent Form

Answer

Case Report Form

Question 3

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

Accepted Answer

Per sponsor protocol and applicable regulations

Answer

Any convenient location accessible to staff

Answer

In the general hospital pharmacy

Answer

At room temperature only

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

To confirm participant eligibility

Answer

To authorize IRB approval

Answer

To record adverse events

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

Dispose of it in regular waste

Answer

Keep it for future studies

Answer

Give it to participants

Question 6

Which temperature monitoring practice is required for investigational products requiring refrigeration?

Accepted Answer

Use calibrated continuous monitoring with excursion documentation

Answer

Check temperature once weekly

Answer

Visual inspection only

Answer

No monitoring required if stored in a standard refrigerator