Trial Procedures 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 Trial Procedures flashcards as text
In clinical trials, what does 'per protocol' (PP) analysis refer to?
Answer: Analyzing only subjects who completed the trial without major protocol deviations
Per protocol analysis includes only subjects who adhered closely to the protocol, providing an estimate of treatment effect under ideal conditions.
Which of the following best describes 'randomization codes' in a blinded clinical trial?
Answer: Codes that determine each subject's treatment assignment and are kept confidential to maintain blinding
Randomization codes determine treatment assignments and are kept confidential to preserve blinding and prevent bias during the trial.
What is the purpose of an emergency unblinding procedure in a clinical trial?
Answer: To reveal a blinded subject's treatment assignment when medically necessary for their immediate care
Emergency unblinding reveals a subject's treatment assignment only when their immediate medical management requires this information.
A sponsor's monitoring plan requires 100% SDV for the first two subjects at each site. After those subjects, what typically guides the SDV approach for remaining subjects?
Answer: A risk-based monitoring strategy that may allow targeted or reduced SDV based on site performance and data risk
Risk-based monitoring uses site performance data and risk assessment to determine appropriate SDV scope after initial intensive review.
What must a site do before destroying any clinical trial records?
Answer: Obtain written authorization from the sponsor and ensure all regulatory retention periods have been met
Records may only be destroyed after receiving written sponsor authorization and confirming that all applicable retention periods have been satisfied.
In a multicenter clinical trial, what is the role of the coordinating investigator?
Answer: To coordinate the conduct of the trial at multiple sites and communicate with the sponsor on behalf of all investigators
The coordinating investigator coordinates trial activities across multiple sites and serves as the primary liaison between the investigator network and the sponsor.
When must a site report an unexpected serious adverse drug reaction (SUSAR) to the regulatory authority?
Answer: Within 7 days for fatal/life-threatening events and 15 days for other unexpected serious adverse reactions
SUSARs that are fatal or life-threatening must be reported within 7 calendar days, and all other SUSARs within 15 calendar days.