CPI Investigator Responsibilities & Reporting 2

Question 1

An investigator discovers a protocol deviation that did not harm the subject but was not pre-approved. What is the FIRST action to take?

Accepted Answer

Report the deviation to the IRB and sponsor per protocol requirements

Answer

Protocol deviations must be reported to the IRB and sponsor promptly, even if no harm occurred, to maintain study integrity.

Question 2

Under 21 CFR Part 312, what is the investigator's obligation when they permanently discontinue or temporarily suspend a clinical investigation?

Accepted Answer

Immediately notify the IRB and the sponsor of the discontinuation

Answer

The investigator must promptly notify both the IRB and sponsor when discontinuing or suspending an investigation.

Question 3

Which of the following best describes the investigator's responsibility regarding the delegation log?

Accepted Answer

It must list all sub-investigators and study staff with their delegated tasks and qualifications

Answer

The delegation log documents all personnel to whom the investigator has delegated study tasks, along with their specific responsibilities and qualifications.

Question 4

A subject enrolled in a trial is found to have falsified their eligibility criteria at screening. What should the investigator do?

Accepted Answer

Document the finding, notify the IRB and sponsor, and determine appropriate action per protocol

Answer

Protocol eligibility violations require notification to the IRB and sponsor, with subject management decisions guided by the protocol and oversight bodies.

Question 5

In the context of CPI responsibilities, what does the term 'sponsor-investigator' mean?

Accepted Answer

An individual who both initiates and conducts a clinical investigation

Answer

A sponsor-investigator is an individual who both initiates and conducts a clinical investigation and assumes all sponsor and investigator responsibilities.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Investigator Responsibilities & Reporting 2