Investigational Product Management & Drug Accountability Flashcards
7 cards from real CPI 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 & Drug Accountability flashcards as text
A site receives an investigational product that requires storage at room temperature (15°C–30°C). The site's storage room routinely reaches 32°C in summer. What should the investigator do?
Answer: Notify the sponsor, identify an appropriate storage area meeting specifications, and do not dispense product until compliant storage is confirmed
Before dispensing, the site must ensure IP is stored per protocol specifications; exceeding the allowed temperature range requires sponsor notification and resolution of the storage issue before any product is used.
What is the purpose of randomization codes or the randomization list in a clinical trial?
Answer: To assign subjects to treatment arms in an unpredictable manner to minimize selection bias
Randomization assigns subjects to treatment groups in an unpredictable, unbiased way, ensuring that known and unknown confounders are evenly distributed across groups.
During an FDA inspection, an investigator is asked to produce documentation that IP was stored under appropriate conditions throughout the trial. Which record is most directly responsive to this request?
Answer: The continuous temperature monitoring logs for the IP storage area
Continuous temperature monitoring logs provide a verifiable record that IP storage conditions remained within protocol-specified ranges for the duration of the study.
A subject in a blinded study takes twice the prescribed dose for one week due to a misunderstanding. Under drug accountability principles, how should this be handled?
Answer: Document the protocol deviation, record the quantity consumed in the accountability log, assess for safety implications, and notify the sponsor and IRB as required
Overdosing constitutes a protocol deviation that must be documented in both the accountability records and the subject's study file, with safety assessment and sponsor/IRB notification per protocol requirements.
What is a 'comparator drug' in the context of investigational product management?
Answer: An approved or investigational drug used as a control or reference treatment against which the experimental drug is evaluated
A comparator drug is an approved or investigational product used as an active control or reference arm so the experimental drug's effects can be evaluated relative to an established treatment.
Which of the following scenarios represents a serious breach of investigational product accountability that must be reported to the sponsor immediately?
Answer: Investigational product is discovered missing from site inventory with no documentation explaining the loss
Unexplained missing investigational product represents a potential diversion, safety hazard, or fraud that requires immediate sponsor notification and investigation to protect trial integrity and subject safety.
When a clinical trial is terminated early, which statement regarding investigational product management is correct?
Answer: IP reconciliation and final disposition (return or destruction per sponsor instructions) must be completed even though the trial ended early
Early termination does not eliminate drug accountability obligations; all IP—dispensed, returned by subjects, and remaining in inventory—must be fully reconciled and disposed of per sponsor instructions with complete documentation.