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

The CRM must proactively notify the sponsor well before expiration to arrange resupply or a protocol amendment, ensuring no interruption in subject dosing with compliant product.

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 principal investigator or treating physician has the authority to unblind a specific subject's treatment assignment in a medical emergency when it is necessary for patient care.

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

IP reconciliation involves verifying that the quantities received, dispensed, returned, and destroyed match accountability records, ensuring there are no unexplained discrepancies.

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 sponsor has primary authority over investigational product disposition, including destruction; the site must follow the sponsor's written instructions and document all destruction activities.

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

Dispensing the wrong dose is a protocol deviation because it constitutes a departure from the approved protocol's dosing instructions and must be documented and reported.

CRM - Clinical Research Manager Certification Practice Test

CRM - Clinical Research Manager Certification Practice Test

CRM Investigational Product Management 3