#1
Which organization is responsible for overseeing the ethical conduct of clinical trials in the United States?
Food and Drug Administration (FDA)
ExplanationFDA oversees ethical conduct of clinical trials in the US.
#2
What is the purpose of the Data Safety Monitoring Board (DSMB) in a clinical trial?
To monitor the safety of participants during the trial
ExplanationDSMB ensures participant safety during trials.
#3
What is the purpose of the protocol in a clinical trial?
To outline the objectives, design, and methodology of the trial
ExplanationProtocol outlines trial objectives and methodology.
#4
What does 'FDA' stand for in the context of regulatory oversight of clinical trials in the United States?
Food and Drug Administration
ExplanationFDA stands for Food and Drug Administration.
#5
What does 'EMA' stand for in the context of regulatory oversight of clinical trials in Europe?
European Medicines Agency
ExplanationEMA stands for European Medicines Agency.
#6
Which of the following is a role of the Clinical Research Coordinator (CRC) in a clinical trial?
Ensuring compliance with regulatory requirements
ExplanationCRC ensures compliance with trial regulations.
#7
What is the primary purpose of obtaining informed consent from participants in a clinical trial?
To ensure participants understand the risks and benefits of participation
ExplanationInformed consent ensures participants understand risks and benefits.
#8
Which of the following is NOT a key principle of research ethics?
Secrecy
ExplanationSecrecy is not a key principle of research ethics.
#9
What is the purpose of the Declaration of Helsinki in the context of medical research?
To ensure the safety and well-being of research participants
ExplanationDeclaration of Helsinki ensures participant safety.
#10
Which of the following is NOT a potential conflict of interest in clinical research?
Personal relationships with study participants
ExplanationPersonal relationships aren't a conflict of interest in research.
#11
Which of the following statements best describes 'placebo' in the context of clinical trials?
An inactive substance or treatment given to participants to compare its effects with those of the active treatment
ExplanationPlacebo is an inactive substance for comparison.
#12
What is the primary role of the sponsor in a clinical trial?
To provide funding and oversee the conduct of the trial
ExplanationSponsor funds and oversees trial conduct.
#13
What is the purpose of the Investigational New Drug (IND) application in the United States?
To allow clinical testing of new drugs in humans
ExplanationIND application permits human testing of new drugs.
#14
What does the term 'randomization' refer to in the context of clinical trials?
Assigning participants to treatment groups by chance
ExplanationRandomization refers to chance-based group assignment.
#15
What is the purpose of the Institutional Review Board (IRB) in a clinical trial?
To ensure the trial is conducted ethically and in compliance with regulations
ExplanationIRB ensures ethical compliance in clinical trials.
#16
What does the acronym 'ICH' stand for in the context of clinical trials?
International Conference on Harmonisation
ExplanationICH stands for International Conference on Harmonisation.
#17
Which of the following statements best describes the concept of 'blinding' in clinical trials?
Both participants and researchers are unaware of treatment assignments
ExplanationBlinding involves keeping both parties unaware of treatments.
#18
Which of the following is an example of therapeutic misconception?
Participants believing that the treatment they receive will cure their condition
ExplanationParticipants believing treatment will cure them.
#19
What is the purpose of the Data and Safety Monitoring Plan (DSMP) in a clinical trial?
To monitor the safety and integrity of trial data
ExplanationDSMP monitors safety and integrity of trial data.
#20
What is the purpose of the International Conference on Harmonisation (ICH) guidelines?
To standardize regulatory requirements for pharmaceuticals
ExplanationICH guidelines standardize pharmaceutical regulations.