Ethics and GCP Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Ethics and GCP flashcards as text
What are the five criteria an IRB must consider when approving research involving human subjects?
Answer: Risks minimized, risks reasonable to benefits, equitable subject selection, informed consent obtained, data safety monitored
IRBs must find that risks are minimized, risks are reasonable relative to benefits, subject selection is equitable, informed consent is obtained, and safety monitoring is adequate.
Under GCP, what is required for a research site to conduct a clinical trial?
Answer: Adequate facilities, qualified staff, IRB approval, and signed agreements with the sponsor
Sites must have adequate facilities and staff, current IRB approval, signed clinical trial agreements, and relevant essential documents in place before initiating a trial.
What is 'research misconduct' in the context of clinical trials?
Answer: Fabrication, falsification, or plagiarism in conducting or reporting research
Research misconduct is defined as fabrication (making up data), falsification (manipulating data), or plagiarism (using others' work without credit) in conducting or reporting research.
What does 'equipoise' mean in clinical research ethics?
Answer: Genuine uncertainty within the expert community about the comparative merits of study treatments
Clinical equipoise is the state of genuine uncertainty in the clinical community about which treatment in a trial is superior, ethically justifying randomization.
What is a 'conflict of interest' in clinical research, and why is it significant?
Answer: A situation where personal or financial interests could unduly influence research decisions, potentially compromising integrity
A conflict of interest occurs when personal, financial, or other interests could compromise research objectivity, potentially biasing outcomes or violating participant protections.
What is the GCP requirement for investigator training and qualifications?
Answer: Investigators must be qualified by education, training, and experience to conduct the specific trial
GCP requires that investigators be qualified by education, training, and experience, and have access to the resources needed to properly conduct the specific trial.