Investigational Product Management Flashcards
7 cards from real CRA 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 purpose of a blinded randomization code in investigational product management?
Answer: To assign subjects to treatment groups while keeping the assignment concealed
A blinded randomization code assigns subjects to treatment groups (active or comparator) while ensuring the assignment remains concealed from site personnel and subjects throughout the trial.
When a subject discontinues from a clinical trial early, what must happen to any remaining investigational product in their possession?
Answer: It must be returned to the site and documented in the drug accountability records
Remaining investigational product from a discontinued subject must be returned to the site and fully documented in drug accountability records to maintain complete accountability.
What is a 'comparator drug' in the context of a randomized controlled clinical trial?
Answer: An approved product or placebo used as a reference treatment against the investigational drug
A comparator drug is an approved medication or placebo used as the reference treatment against which the investigational product's safety and efficacy are compared.
Which of the following best describes what a CRA is verifying when conducting an investigational product accountability review?
Answer: That all IP received, dispensed, on hand, returned, and destroyed is documented and quantities balance
IP accountability verification confirms that total IP received equals the sum of IP dispensed to subjects, currently on hand, returned to sponsor, and destroyed, with full supporting documentation.
What is the primary risk when a site fails to maintain adequate temperature monitoring records for investigational product storage?
Answer: Regulatory findings, protocol deviations, and data integrity concerns that could compromise the trial
Inadequate temperature monitoring records can result in regulatory findings, protocol deviations, and data integrity questions that could compromise trial data and the approvability of the drug.
Under ICH E6(R2) GCP guidelines, who must be authorized to access investigational product at a clinical site?
Answer: Only individuals formally authorized and listed on the site delegation log
ICH E6(R2) requires that only personnel formally authorized and listed on the site delegation log may access investigational product, ensuring controlled and accountable handling.
What must a CRA document after completing an investigational product accountability review during a monitoring visit?
Answer: All findings, any discrepancies identified, and confirmation that accountability records are complete and accurate
The monitoring visit report must document all IP accountability findings, including any discrepancies identified, corrective actions required, and confirmation that records are complete and accurate.