OCC Clinical Trials & Evidence-Based Practice Flashcards
6 cards from real OCC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 OCC Clinical Trials & Evidence-Based Practice flashcards as text
Which document outlines the ethical principles for conducting research involving human subjects and forms the foundation of clinical trial ethics in the US?
Answer: Belmont Report
The Belmont Report (1979) established the foundational ethical principles of respect for persons, beneficence, and justice for all US federally funded human subjects research.
A patient enrolled in a Phase I clinical trial asks the nurse what the primary goal of this phase is. What is the correct response?
Answer: To evaluate the drug's safety, tolerability, and maximum tolerated dose in humans
Phase I trials primarily establish safety, tolerability, pharmacokinetics, and maximum tolerated dose in a small group of patients, not efficacy.
Which element is REQUIRED for a patient to provide valid informed consent for clinical trial participation?
Answer: Voluntary participation, disclosure of all risks and benefits, and patient comprehension
Valid informed consent requires voluntary participation free from coercion, full disclosure of risks and benefits, and confirmation that the patient understands the information.
What is the nurse's role when a patient enrolled in a blinded randomized controlled trial asks which treatment arm they are in?
Answer: Explain the concept of blinding and that this information is protected to maintain trial integrity
In blinded trials, the nurse must explain that blinding protects scientific integrity and that the information cannot be shared without compromising the trial's validity.
A nurse notes an unexpected serious adverse event in a patient on a clinical trial. What is the MOST important immediate action?
Answer: Document the event in the chart, report to the principal investigator immediately, and complete the adverse event report per protocol
Serious adverse events must be documented, immediately reported to the PI, and captured in the adverse event reporting system per the protocol's safety monitoring plan.
A patient on a clinical trial wants to withdraw from the study. What does the nurse explain about their rights?
Answer: The patient can withdraw at any time without penalty or loss of standard care benefits
Patients have the right to withdraw from any clinical trial at any time without penalty, coercion, or loss of access to standard care, as guaranteed by federal research ethics regulations.
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