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

45 CFR Part 46

Answer

21 CFR Part 11

Answer

ICH E6 R2

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

Adverse Event Form

Answer

Protocol Deviation Report

Answer

Informed Consent Form

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

Sponsor's medical monitor

Answer

IRB coordinator

Answer

FDA inspector

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

−20°C to −15°C

Answer

15°C to 25°C

Answer

30°C to 40°C

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

Discarded immediately by the subject

Answer

Donated to another enrolled subject

Answer

Sent directly back to the sponsor without logging

Question 6

A temperature excursion is discovered in the investigational product storage area. What is the FIRST action a Clinical Research Manager should take?

Accepted Answer

Notify the sponsor and document the excursion per protocol

Answer

Destroy the affected product immediately

Answer

Dispense the product before further degradation

Answer

Transfer product to another freezer without reporting

Question 7

Which GCP guideline requires that investigational products be manufactured, handled, and stored in accordance with Good Manufacturing Practice (GMP)?

Accepted Answer

ICH E6 (R2)

Answer

ICH E3

Answer

ICH E9

Answer

ICH E2A