SOCRA CCRP Investigational Product Management

Question 1

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

Accepted Answer

The principal investigator or designee

Answer

The sponsor's monitor

Answer

The IRB/IEC

Answer

The site's pharmacy regulatory board

Question 2

According to ICH GCP E6(R2), investigational products must be stored under conditions specified by:

Accepted Answer

The sponsor's protocol and investigational product information

Answer

The site's standard operating procedures

Answer

The IRB approval letter

Answer

FDA general pharmaceutical storage guidelines

Question 3

What document is used at a clinical trial site to track all dispensing, administration, and returns of investigational product?

Accepted Answer

Investigational Product Accountability Log

Answer

Case Report Form (CRF)

Answer

Protocol Deviation Log

Answer

Source document worksheets

Question 4

When an investigational product shipment is received at a clinical site, what is the FIRST action the site should take?

Accepted Answer

Inspect and document the shipment against the packing slip and protocol requirements

Answer

Begin dispensing immediately to enrolled subjects

Answer

Notify the IRB of shipment receipt

Answer

Destroy the outer packaging

Question 5

A temperature excursion is detected in the IP storage refrigerator over a weekend. What is the appropriate FIRST action?

Accepted Answer

Quarantine the affected IP and notify the sponsor

Answer

Dispose of all affected IP immediately

Answer

Continue using the IP and document the excursion in the deviation log

Answer

Return the IP to the subject and document the event

Question 6

At study close-out, what typically happens to unused investigational product?

Accepted Answer

It is returned to the sponsor or destroyed per sponsor instructions with full documentation

Answer

It is discarded by the site pharmacy at their discretion

Answer

It is kept by the site for potential future use

Answer

It is donated to the local hospital pharmacy

Question 7

Which of the following best describes 'blinded' investigational product in a randomized controlled trial?

Accepted Answer

IP where the identity of active drug versus placebo is concealed from participants and/or investigators

Answer

IP that has been destroyed and is no longer usable

Answer

IP stored in a dark environment to prevent photodegradation

Answer

IP that has failed quality control testing