CATO Associate Investigational Product Management Flashcards
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Read the first 6 CATO Associate Investigational Product Management flashcards as text
Which of the following is TRUE regarding the destruction of unused investigational product?
Answer: IP must be destroyed only after sponsor authorization and per local regulations, with documentation
IP destruction requires written sponsor authorization, must comply with local regulations, and must be documented with a destruction certificate.
What is the significance of the 'lot number' on investigational product labels?
Answer: It enables traceability of the product batch for quality and recall purposes
The lot number on IP labeling allows the manufacturer to trace the specific production batch, supporting quality control and recall management if needed.
Why must investigational product never be dispensed to a subject before randomization?
Answer: Because pre-randomization dispensing violates the protocol and could compromise blinding and data integrity
Dispensing IP before randomization is a protocol deviation that compromises trial integrity and subject allocation to treatment arms.
What is an 'IP inventory log' used for at a clinical site?
Answer: To record current stock levels of IP at the site for accountability and re-order purposes
The IP inventory log tracks the current stock of investigational product at the site, enabling the sponsor to manage supply chain and ensure availability.
In a clinical trial, what is a 'comparator product'?
Answer: An approved or investigational product used as a reference in a controlled trial for comparison with the investigational product
A comparator product is an approved or investigational agent used as a control against which the investigational product's effects are compared.
What should a CRA do if drug accountability records do not reconcile during a monitoring visit?
Answer: Document the discrepancy, investigate the cause with site staff, and report findings to the sponsor
Unresolved drug accountability discrepancies must be documented, investigated with site staff, and escalated to the sponsor for review.