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 correct action when investigational product at a site reaches its expiration date?
Answer: Quarantine the expired product, notify the sponsor, and arrange disposal per protocol
Expired IP must be quarantined and removed from use immediately; the sponsor must be notified and disposal must follow the protocol's or sponsor's destruction instructions.
What is a drug destruction certificate in the context of clinical trials?
Answer: An official document certifying that unused or expired IP was destroyed per regulatory requirements
A drug destruction certificate documents that unused or expired investigational product was destroyed in accordance with applicable regulations and sponsor instructions, completing the accountability chain.
How should a temperature excursion affecting investigational product be handled at a clinical trial site?
Answer: Document the excursion, quarantine the affected product, and notify the sponsor for disposition guidance
Any temperature excursion must be documented and the affected product quarantined; the sponsor must be notified to evaluate whether the IP is still suitable for use or must be destroyed.
What is the primary purpose of a drug accountability binder maintained at a clinical trial site?
Answer: To provide a centralized, auditable record of all IP transactions including receipts, dispensing, returns, and destruction
The drug accountability binder consolidates all IP transaction records in one location, enabling auditors and monitors to verify that all product is fully accounted for throughout the trial.
Who must authorize any changes to investigational product storage conditions at a clinical trial site?
Answer: The sponsor or designee, typically in writing before implementation
Storage condition changes must be pre-approved by the sponsor in writing because the sponsor is responsible for maintaining IP quality and any deviation requires formal authorization to ensure regulatory compliance.
What is 'unblinding' and under what circumstance is it permitted during a clinical trial?
Answer: Revealing a specific participant's treatment assignment, typically only in a medical emergency requiring knowledge of treatment to guide care
Unblinding is the disclosure of a participant's treatment assignment and is only permitted in a genuine medical emergency where the treating physician needs treatment information to manage the participant's care.
According to GCP, how frequently should a clinical monitor verify IP accountability records at the site?
Answer: During each monitoring visit throughout the study
GCP E6 requires monitors to verify IP accountability records at each monitoring visit to detect discrepancies early and ensure ongoing compliance with storage and dispensing requirements.