SOCRA Investigational Product Management 2

Question 1

When investigational product (IP) is received at a clinical site, what is the FIRST action the site coordinator should take?

Accepted Answer

Inspect the shipment and verify contents against the packing list and shipping manifest

Answer

Immediately dispense IP to enrolled subjects

Answer

File the shipping documents without opening the package

Answer

Notify the IRB of the IP receipt

Question 2

A temperature excursion is discovered after IP has been stored at the site for two weeks. What should the CRC do?

Accepted Answer

Quarantine the affected IP and notify the sponsor immediately for guidance

Answer

Discard the IP immediately and reorder

Answer

Continue using the IP since two weeks have passed without incident

Answer

Dispense remaining IP before reporting the excursion

Question 3

Which document specifically tracks the movement of investigational product from the manufacturer to the investigator site?

Accepted Answer

Chain of Custody / Shipping manifest

Answer

Investigator Brochure

Answer

Protocol amendment

Answer

Informed consent form

Question 4

An investigational drug requires storage at 2–8°C. The site refrigerator maximum alarm was triggered over a weekend. What is the appropriate response?

Accepted Answer

Document the excursion, quarantine affected IP, and contact the sponsor for disposition instructions

Answer

Reset the alarm and continue using the IP

Answer

Move the IP to a staff member's home refrigerator

Answer

Use the IP within 24 hours to avoid waste

Question 5

Under ICH E6(R2), who is responsible for ensuring that investigational product at the site is stored according to protocol specifications?

Accepted Answer

The Principal Investigator

Answer

The IRB/IEC

Answer

The Sponsor only

Answer

The contract research organization's monitor

Question 6

What is the purpose of a drug accountability log in a clinical trial?

Accepted Answer

To record all IP received, dispensed, returned, and destroyed at the site

Answer

To track subject adverse events related to the study drug

Answer

To document pharmacy staff credentials

Answer

To summarize IP costs for budget reconciliation

Question 7

A site receives IP with a label stating 'For Investigational Use Only — Not for Sale.' This labeling requirement is mandated by which regulation?

Accepted Answer

21 CFR Part 312.6

Answer

21 CFR Part 50

Answer

21 CFR Part 56

Answer

ICH E8