Emergency Procedures & Response 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 Emergency Procedures & Response flashcards as text
A participant in a blinded clinical trial requires emergency surgery and the surgeon needs to know the study drug. What is the correct action?
Answer: Use the emergency unblinding procedure to reveal the participant's treatment assignment
Emergency unblinding procedures exist to protect participant safety; the investigator should use the defined emergency unblinding process immediately.
After an emergency unblinding event, which action must the investigator take regarding the IRB?
Answer: Notify the IRB and sponsor of the unblinding event and its circumstances
Investigators must promptly report emergency unblinding events to both the IRB and sponsor, documenting the reason and outcome.
A subject enrolled in a cardiac drug trial develops anaphylaxis. The first priority of the investigator-physician is to:
Answer: Administer emergency treatment regardless of protocol restrictions
The immediate medical welfare of the participant takes absolute precedence over protocol adherence or documentation in a life-threatening emergency.
Which document should an investigator reference first when a study participant presents with a potential overdose of the investigational product?
Answer: The Investigator's Brochure (IB) toxicity and overdose management section
The Investigator's Brochure contains known toxicity data, overdose management guidance, and relevant safety information for the investigational product.
Under 21 CFR Part 50, exception from informed consent for emergency research applies when all of the following are true EXCEPT:
Answer: The subject has a legally authorized representative available to consent
Exception from informed consent under 21 CFR 50.24 requires that consent cannot be obtained from the subject or LAR; if an LAR is available and accessible, consent must be sought.
A Data Safety Monitoring Board (DSMB) recommends immediate trial suspension due to a safety signal. The investigator's responsibility is to:
Answer: Immediately halt enrollment and notify all participants currently on study drug
Upon a DSMB safety-based suspension recommendation communicated through the sponsor, investigators must immediately halt enrollment and take steps to protect current participants.
When a serious adverse event (SAE) occurs during a clinical trial, the FDA requires the sponsor to submit an IND Safety Report within how many calendar days for unexpected fatal or life-threatening events?
Answer: 7 days
Under 21 CFR 312.32, unexpected fatal or life-threatening suspected adverse reactions must be reported to the FDA within 7 calendar days.