CRM Investigational Product Management 3

Question 1

What action should a Clinical Research Manager take when investigational product expiration dates are approaching and subjects are still enrolled?

Accepted Answer

Notify the sponsor in advance to arrange resupply or protocol amendment

Answer

Continue dispensing the expired product if appearance is unchanged

Answer

Dispose of the product and pause all dosing without notification

Answer

Transfer product from another site to extend the supply

Question 2

In a double-blind trial, which party is typically authorized to break the blind for an individual subject in a medical emergency?

Accepted Answer

The principal investigator or treating physician

Answer

The site's IRB administrator

Answer

The data safety monitoring board chair

Answer

The trial's biostatistician

Question 3

What does 'IP reconciliation' refer to at the close of a clinical trial?

Accepted Answer

Verifying that all IP received, dispensed, and returned/destroyed is fully accounted for with no discrepancies

Answer

Reviewing financial payments made to investigators

Answer

Auditing subject visit schedules against the protocol

Answer

Comparing IRB approval letters to protocol amendments

Question 4

Who has primary authority to approve investigational product destruction at a clinical trial site?

Accepted Answer

The sponsor, per their written instructions or protocol

Answer

The site's IRB

Answer

The FDA district office

Answer

The hospital's pharmacy director acting alone

Question 5

Which of the following would be considered a protocol deviation related to investigational product?

Accepted Answer

Dispensing the wrong dose of investigational product to a subject

Answer

A subject arriving 5 minutes late to a non-dosing visit

Answer

A sponsor changing the trial's primary endpoint

Answer

An IRB renewing annual approval one day early

Question 6

What is the significance of the expiration date on an investigational product label?

Accepted Answer

It marks the date after which the product's safety and efficacy can no longer be guaranteed by testing

Answer

It indicates when the product must be returned to the sponsor for repackaging

Answer

It specifies when the IRB approval for that product batch expires

Answer

It triggers automatic enrollment closure for the trial

Question 7

A Clinical Research Manager notices that the investigational product storage temperature log shows a gap of 48 hours with no recorded readings. What is the most appropriate next step?

Accepted Answer

Investigate the cause of the gap, document the finding, notify the sponsor, and quarantine the product pending sponsor assessment

Answer

Assume the temperature was stable and continue dispensing

Answer

Discard all product stored during that period without notifying the sponsor

Answer

Ask a staff member to backfill the missing readings from memory