Treatment Planning & Protocols Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Treatment Planning & Protocols flashcards as text
A protocol amendment changes the primary endpoint of an ongoing clinical trial. What is the MOST important immediate action the investigator must take?
Answer: Submit the amendment to the IRB and obtain approval before implementing
Protocol amendments that alter primary endpoints require IRB review and approval before implementation.
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?
Answer: Dose-Limiting Toxicity — to evaluate safety before escalating to the next cohort
DLT (Dose-Limiting Toxicity) observation periods ensure safety data are collected before exposing new subjects to higher doses.
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?
Answer: Contact the sponsor's medical monitor for guidance before making any change
When protocol guidance is absent, the investigator should contact the sponsor's medical monitor to ensure consistent decision-making across sites.
Which element is MOST essential when developing a treatment protocol for a Phase I first-in-human study?
Answer: Detailed stopping rules and dose escalation criteria based on preclinical data
Phase I first-in-human studies require rigorous stopping rules and dose escalation criteria derived from preclinical safety data to protect subjects.
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:
Answer: Protocol deviation that must be documented and reported per study procedures
Consistent departure from protocol-specified administration conditions is a protocol deviation requiring documentation and reporting.
When a protocol specifies 'washout period' requirements before study drug initiation, the primary purpose is to:
Answer: Eliminate prior treatment effects that could confound study results or cause interactions
Washout periods eliminate residual effects of prior treatments to reduce confounding and prevent drug-drug interactions.
A randomized controlled trial uses a PROBE design. What does PROBE stand for?
Answer: Prospective Randomized Open Blinded End-point
PROBE (Prospective Randomized Open Blinded End-point) uses open-label treatment assignment but blinded endpoint assessment to reduce bias.