#1
Which of the following is a key responsibility of a clinical research coordinator?
Obtaining informed consent from study participants
ExplanationEnsuring participants understand and agree to participate in research.
#2
Which regulatory body oversees clinical trials in the United States?
FDA
ExplanationEnsuring safety and efficacy of drugs and medical devices.
#3
What is the purpose of an Institutional Review Board (IRB) in clinical research?
To review and approve research studies involving human participants
ExplanationSafeguarding participants' rights and welfare.
#4
Which of the following is NOT a common responsibility of a clinical investigator?
Prescribing medications for study participants
ExplanationDirectly providing medical treatment during trials.
#5
Which document outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial?
Protocol
ExplanationBlueprint for conducting a clinical trial.
#6
Which of the following is NOT a common ethical consideration in clinical research?
Conducting research without approval
ExplanationNeglecting ethical oversight in research.
#7
Which of the following is a key requirement for Good Clinical Practice (GCP)?
Adhering to ethical principles and regulatory requirements
ExplanationMaintaining high standards in clinical research.
#8
Who is responsible for ensuring that clinical trial data is accurately recorded and reported?
Principal investigator
ExplanationOverseeing data collection and reporting.
#9
Which of the following is a key aspect of compliance in clinical research?
Adhering to the study protocol and regulatory requirements
ExplanationFollowing established guidelines and rules.
#10
What is the primary purpose of the Declaration of Helsinki in clinical research?
To provide guidelines for the conduct of research involving human participants
ExplanationUpholding ethical standards in research.
#11
Which of the following is a key aspect of ensuring data integrity in clinical research?
Maintaining accurate and complete records
ExplanationAvoiding data manipulation and errors.
#12
Which of the following is a key aspect of maintaining confidentiality in clinical research?
Storing participant identifiers separately from research data
ExplanationProtecting participant privacy and anonymity.