CPI Emergency Procedures & Response 2 — Questions and Answers
Question 1: A participant in a blinded clinical trial requires emergency surgery and the surgeon needs to know the study drug. What is the correct action?
- Contact the sponsor's medical monitor first
- Use the emergency unblinding procedure to reveal the participant's treatment assignment (Correct answer)
- Treat the participant as if on placebo until the blind can be broken formally
- Discontinue the participant without unblinding
Correct 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.
Question 2: After an emergency unblinding event, which action must the investigator take regarding the IRB?
- No notification is required if the participant recovered fully
- Notify the IRB only if the event was fatal
- Notify the IRB and sponsor of the unblinding event and its circumstances (Correct answer)
- Notify the IRB only at the next scheduled continuing review
Correct 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.
Question 3: A subject enrolled in a cardiac drug trial develops anaphylaxis. The first priority of the investigator-physician is to:
- Document the adverse event before beginning treatment
- Administer emergency treatment regardless of protocol restrictions (Correct answer)
- Contact the IRB for emergency authorization to treat
- Withdraw the subject from the study before administering epinephrine
Correct 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.
Question 4: Which document should an investigator reference first when a study participant presents with a potential overdose of the investigational product?
- The protocol appendix on discontinuation criteria
- The Investigator's Brochure (IB) toxicity and overdose management section (Correct answer)
- The IRB approval letter
- The FDA 1572 form
Correct 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.
Question 5: Under 21 CFR Part 50, exception from informed consent for emergency research applies when all of the following are true EXCEPT:
- The subject is in a life-threatening situation
- Available treatments are unproven or unsatisfactory
- The subject has a legally authorized representative available to consent (Correct answer)
- Obtaining consent is not feasible
Correct 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.
Question 6: A Data Safety Monitoring Board (DSMB) recommends immediate trial suspension due to a safety signal. The investigator's responsibility is to:
- Continue enrolling until the sponsor issues an official stop order
- Immediately halt enrollment and notify all participants currently on study drug (Correct answer)
- Await IRB confirmation before stopping any study activities
- Continue only with participants already enrolled but stop new enrollment
Correct 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.
Question 7: 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?
- 30 days
- 7 days (Correct answer)
- 15 days
- 24 hours
Correct 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.
CPI Emergency Procedures & Response 2
A participant in a blinded clinical trial requires emergency surgery and the surgeon needs to know the study drug.
What is the correct action?