CRM Investigational Product Management

Question 1

Which federal regulation governs the accountability and handling of investigational drugs in clinical trials in the United States?

Accepted Answer

21 CFR Part 312

Answer

21 CFR Part 312 establishes FDA requirements for Investigational New Drug (IND) applications, including investigational product accountability and handling.

Question 2

What document is used to track the receipt, dispensing, return, and destruction of investigational product at a clinical trial site?

Accepted Answer

Drug Accountability Log

Answer

A Drug Accountability Log (also called IP Accountability Log) records all movements of investigational product including receipt, dispensing, returns, and destruction.

Question 3

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

Accepted Answer

Site pharmacist or designated investigator

Answer

The site pharmacist or the principal investigator (or their designee) is responsible for maintaining IP accountability records per ICH GCP and FDA regulations.

Question 4

What is the required temperature range for storing most standard investigational biologics that must be refrigerated?

Accepted Answer

2°C to 8°C

Answer

Refrigerated biologics and many investigational drugs require storage between 2°C and 8°C to maintain product integrity and potency.

Question 5

When an investigational product is dispensed to a subject who later withdraws from the study, the unused product should be:

Accepted Answer

Returned to the site and documented in the accountability log

Answer

Unused investigational product must be returned to the site and documented in the accountability log to maintain accurate inventory records and chain of custody.

CRM - Clinical Research Manager Certification Practice Test

CRM - Clinical Research Manager Certification Practice Test

CRM Investigational Product Management