Investigational Product Management Flashcards
7 cards from real CRM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigational Product Management flashcards as text
What action should a Clinical Research Manager take when investigational product expiration dates are approaching and subjects are still enrolled?
Answer: Notify the sponsor in advance to arrange resupply or protocol amendment
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.
In a double-blind trial, which party is typically authorized to break the blind for an individual subject in a medical emergency?
Answer: The principal investigator or treating physician
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.
What does 'IP reconciliation' refer to at the close of a clinical trial?
Answer: Verifying that all IP received, dispensed, and returned/destroyed is fully accounted for with no discrepancies
IP reconciliation involves verifying that the quantities received, dispensed, returned, and destroyed match accountability records, ensuring there are no unexplained discrepancies.
Who has primary authority to approve investigational product destruction at a clinical trial site?
Answer: The sponsor, per their written instructions or protocol
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.
Which of the following would be considered a protocol deviation related to investigational product?
Answer: Dispensing the wrong dose of investigational product to a subject
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.
What is the significance of the expiration date on an investigational product label?
Answer: It marks the date after which the product's safety and efficacy can no longer be guaranteed by testing
The expiration date is the date established by stability testing after which the product's potency, purity, and safety cannot be assured, and it must not be dispensed to subjects.
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?
Answer: Investigate the cause of the gap, document the finding, notify the sponsor, and quarantine the product pending sponsor assessment
A monitoring gap is a potential excursion event; the CRM must investigate, document, quarantine affected product, and notify the sponsor to assess product integrity before further dispensing.