CPI Emergency Procedures & Response 3

Question 1

A clinical trial participant becomes incapacitated mid-study and can no longer provide ongoing consent. The investigator should:

Accepted Answer

Obtain consent from a legally authorized representative and reassess continued participation

Answer

When a participant loses capacity, a legally authorized representative must be engaged to provide proxy consent before study procedures continue.

Question 2

An investigator discovers a protocol deviation occurred during an emergency—study drug was given outside the dosing window to stabilize a participant. This should be:

Accepted Answer

Documented and reported to the IRB and sponsor per protocol deviation procedures

Answer

All protocol deviations, including those made for emergency medical reasons, must be documented and reported to both the IRB and sponsor.

Question 3

Which regulatory pathway allows emergency use of an unapproved drug outside of a clinical trial when no alternatives exist?

Accepted Answer

Expanded access (compassionate use) under 21 CFR 312.310

Answer

21 CFR 312.310 governs individual patient expanded access (compassionate use) for emergency situations where no alternatives are available.

Question 4

A study participant is hospitalized for an SAE. The investigator's source document responsibilities include:

Accepted Answer

Hospital records, lab results, and a narrative linking the event to study participation

Answer

Complete source documentation for SAEs includes all medical records, lab data, and a narrative account regardless of causality assessment.

Question 5

During a clinical trial, a participant suffers a stroke. The investigator assesses causality as 'unlikely related' to study drug. This assessment:

Accepted Answer

Does not affect the reporting obligation; all SAEs must be reported to the sponsor

Answer

All serious adverse events must be reported to the sponsor regardless of the investigator's causality assessment; the sponsor then makes relatedness determinations for FDA reporting.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Emergency Procedures & Response 3