CPI Investigator Responsibilities & Reporting 3

Question 1

How long must clinical investigators retain study records after the completion or discontinuation of the clinical investigation under FDA regulations?

Accepted Answer

2 years after the date a marketing application is approved or discontinued

Answer

Under 21 CFR 312.62, investigators must retain records for 2 years after the date a marketing application is approved or after investigation is discontinued.

Question 2

A sub-investigator at a clinical trial site wants to enroll a relative as a research subject. What is the BEST course of action?

Accepted Answer

Decline enrollment or ensure an independent evaluator obtains consent to avoid undue influence

Answer

Enrolling relatives creates a coercive situation; an independent party should obtain consent or the subject should not be enrolled to protect voluntary participation.

Question 3

What is the investigator's responsibility when the IRB requests modifications to the study protocol before granting approval?

Accepted Answer

Implement the requested modifications and resubmit for IRB review before starting the study

Answer

Investigators must not begin a study until the IRB has reviewed and approved the protocol, including any modifications the IRB requires.

Question 4

An investigator conducting a multi-site trial identifies that another site is not following GCP. What is their responsibility?

Accepted Answer

Report concerns to the sponsor so the sponsor can address the issue with the non-compliant site

Answer

An investigator's primary responsibility is to their own site; concerns about other sites should be escalated to the sponsor, who bears oversight responsibility across all sites.

Question 5

Which of the following constitutes a 'serious breach' of GCP that an investigator must report to the sponsor immediately?

Accepted Answer

Enrollment of a subject who did not meet inclusion/exclusion criteria without prior authorization

Answer

Enrolling subjects who do not meet eligibility criteria is a serious breach that jeopardizes subject safety and data integrity, requiring immediate reporting.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Investigator Responsibilities & Reporting 3