Phase I-IV Clinical Trials 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 Phase I-IV Clinical Trials flashcards as text
In Phase I trials involving healthy volunteers, which of the following adverse events would most likely trigger an immediate clinical hold by the FDA?
Answer: An unexpected serious adverse event that suggests significant risk to participants
The FDA may impose a clinical hold if an unexpected SAE suggests unreasonable or significant risk to trial participants.
What is the key purpose of an End-of-Phase II (EOP2) meeting with the FDA?
Answer: To discuss the adequacy of Phase II data and agree on the Phase III design
The EOP2 meeting allows the sponsor and FDA to reach agreement on the Phase III trial design, including endpoints, sample size, and study population, before major investment.
Which type of Phase II trial design includes a single active treatment arm with no concurrent control group?
Answer: Single-arm trial
A single-arm trial enrolls all subjects into one treatment group and compares outcomes to a pre-specified historical control or benchmark.
A Phase III trial uses an independent Data Safety Monitoring Board (DSMB). What is the DSMB's primary role?
Answer: To review unblinded interim safety and efficacy data and recommend continuation, modification, or termination
The DSMB independently reviews unblinded interim data to protect subject safety and ensure trial integrity, with authority to recommend stopping the trial.
In Phase IV surveillance, what is the primary goal of a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: To ensure that the benefits of a drug outweigh its risks in the post-market setting
A REMS is an FDA-required risk management plan designed to ensure that the benefits of a drug or biological product outweigh its known risks in real-world use.
A sponsor is designing a Phase I trial for a monoclonal antibody. What is the most appropriate starting dose selection approach recommended by the FDA?
Answer: Use the human equivalent dose calculated from the highest non-severely toxic dose (HNSTD) in animal studies
For biologics such as monoclonal antibodies, the FDA recommends deriving the starting dose from the HNSTD in the most sensitive relevant animal species.
During a Phase III trial, a subject in the active treatment arm experiences a Suspected Unexpected Serious Adverse Reaction (SUSAR). Within what timeframe must the sponsor report a fatal or life-threatening SUSAR to the FDA?
Answer: Within 7 calendar days
Fatal or life-threatening SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial receipt of the information.