CPI Emergency Procedures & Response 2

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?

Accepted Answer

Use the emergency unblinding procedure to reveal the participant's treatment assignment

Answer

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?

Accepted Answer

Notify the IRB and sponsor of the unblinding event and its circumstances

Answer

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:

Accepted Answer

Administer emergency treatment regardless of protocol restrictions

Answer

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?

Accepted Answer

The Investigator's Brochure (IB) toxicity and overdose management section

Answer

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:

Accepted Answer

The subject has a legally authorized representative available to consent

Answer

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.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Emergency Procedures & Response 2