Exam Questions and CORRECT Answers
What is a Phase II trial? - CORRECT ANSWER - The primary goal is to determine the
efficacy of a new agent in the treatment of specific types of cancer, validate toxicity, dosage data,
administrative guidelines, and supportive care
What is informed consent? - CORRECT ANSWER - Detailed communication about the
diagnosis and treatment between the medical team and the patient of caregiver
What is the Nuremberg Code? - CORRECT ANSWER - The first document written to address
ethics associated with human subject participation in scientific studies
What is the Belmont Report? - CORRECT ANSWER - Written by the US National
Commission and has three main concerns
Food and Drug Administration
Office of Human Research Protections (OHRP)
Institutional Review Board
National Cancer Institute - CORRECT ANSWER - Name two regulatory groups specific in
the oversight of clinical trials
What is beneficence? - CORRECT ANSWER - The obligation to do no harm, maximize the
possible benefits, minimize possible harms.
Patient Rights
Nursing Standards of Care
Medication Errors
Documentation