Investigational Product Management Flashcards
7 cards from real CTA 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 is the significance of lot numbers for investigational products in clinical trials?
Answer: They allow tracking of product batches for quality control, recalls, and accountability purposes
Lot numbers link each IP unit to a specific manufacturing batch, enabling the sponsor to trace product quality, issue targeted recalls if needed, and maintain complete accountability records.
How should investigational products be reconciled at the end of a clinical trial?
Answer: All dispensed, returned, and destroyed IP quantities are accounted for against total received to verify no unexplained discrepancies
End-of-study reconciliation requires verifying that the total IP received equals the sum of IP dispensed plus returned plus destroyed, with no unexplained units, ensuring full chain-of-custody compliance.
What is a Certificate of Analysis (CoA) for investigational products and why is it important?
Answer: A document from the manufacturer certifying that a specific IP lot meets defined quality specifications
A CoA issued by the manufacturer confirms that the specific IP lot was tested and meets all quality, purity, and potency specifications, providing documentation of product integrity before use in participants.
What information must be documented each time investigational product is dispensed to a trial participant?
Answer: Participant ID, date, kit or lot number, dose dispensed, quantity, and the name of the person who dispensed it
Each dispensing entry must capture who received the IP, when, what was given (lot/kit number, dose, quantity), and who dispensed it to create a complete, auditable accountability record.
What is a 're-supply request' in the context of investigational product management?
Answer: A formal request from the site to the sponsor to ship additional IP when supplies are running low
A re-supply request is initiated by the site when IP inventory reaches a pre-defined threshold, triggering the sponsor to ship additional product to prevent treatment interruptions for enrolled participants.
What is the role of the investigational site pharmacy in clinical trial IP management?
Answer: The pharmacy is responsible for IP receipt, storage, randomization, dispensing, and accountability documentation per protocol
The investigational pharmacy oversees all IP handling functions at the site, including secure storage, randomization kit assignment, dispensing to participants, and maintaining complete accountability records.
What does 'comparator product' mean in the context of investigational product management?
Answer: An approved drug or placebo used alongside the investigational drug to compare efficacy and safety in the trial
A comparator product is an approved drug (or placebo) used in the control arm of a trial to compare outcomes against the investigational treatment, requiring the same IP accountability and storage standards.