CPI Treatment Planning & Protocols 2

Question 1

A protocol amendment changes the primary endpoint of an ongoing clinical trial. What is the MOST important immediate action the investigator must take?

Accepted Answer

Submit the amendment to the IRB and obtain approval before implementing

Answer

Protocol amendments that alter primary endpoints require IRB review and approval before implementation.

Question 2

In a dose-escalation trial, the protocol specifies a 'DLT observation period' of 28 days. What does DLT stand for and why is this period critical?

Accepted Answer

Dose-Limiting Toxicity — to evaluate safety before escalating to the next cohort

Answer

DLT (Dose-Limiting Toxicity) observation periods ensure safety data are collected before exposing new subjects to higher doses.

Question 3

A subject enrolled in a cancer trial develops a grade 3 adverse event that is not listed in the protocol's dose modification table. What should the investigator do?

Accepted Answer

Contact the sponsor's medical monitor for guidance before making any change

Answer

When protocol guidance is absent, the investigator should contact the sponsor's medical monitor to ensure consistent decision-making across sites.

Question 4

Which element is MOST essential when developing a treatment protocol for a Phase I first-in-human study?

Accepted Answer

Detailed stopping rules and dose escalation criteria based on preclinical data

Answer

Phase I first-in-human studies require rigorous stopping rules and dose escalation criteria derived from preclinical safety data to protect subjects.

Question 5

A protocol mandates that study drug be administered within 30 minutes of a meal. A subject consistently takes the drug 60 minutes after eating. This represents a:

Accepted Answer

Protocol deviation that must be documented and reported per study procedures

Answer

Consistent departure from protocol-specified administration conditions is a protocol deviation requiring documentation and reporting.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Treatment Planning & Protocols 2