#1
Which organization oversees clinical trial monitoring and compliance?
Food and Drug Administration (FDA)
ExplanationFDA ensures adherence to regulations.
#2
Which of the following is a common method for monitoring clinical trials?
On-site visits
ExplanationRegular on-site checks.
#3
Which phase of clinical trials involves a small group of people to assess safety and dosage?
Phase 1
ExplanationInitial safety and dosage assessment.
#4
Which of the following is NOT a phase of clinical trials?
Phase 5
ExplanationPhase 5 is not part of clinical trials.
#5
Which regulatory authority is responsible for approving new drugs in the United States?
Food and Drug Administration (FDA)
ExplanationFDA approves new drugs.
#6
Which phase of clinical trials involves comparing the new treatment to the standard treatment?
Phase 3
ExplanationComparison with standard treatment.
#7
What is the primary goal of clinical trial monitoring?
To protect the rights, safety, and well-being of human subjects
ExplanationEnsuring human subject safety.
#8
What does GCP stand for in the context of clinical trials?
Good Clinical Practice
ExplanationStandard guidelines for trials.
#9
What is the purpose of an Institutional Review Board (IRB) in clinical trials?
To ensure compliance with local regulations and ethical standards
ExplanationOverseeing compliance and ethics.
#10
Which of the following is NOT typically included in an informed consent form for a clinical trial?
Details of compensation for participation
ExplanationCompensation details not in consent form.
#11
What is the role of a Clinical Research Associate (CRA) in clinical trial monitoring?
To monitor and ensure compliance with the protocol and regulations
ExplanationMonitoring and ensuring adherence.
#12
What is the purpose of randomization in clinical trials?
To ensure that participants have equal access to treatment
ExplanationEqual treatment access.
#13
Which of the following is NOT a potential consequence of non-compliance in clinical trials?
Approval of trial results
ExplanationNon-compliance affects approval.
#14
What is the purpose of a Data Safety Monitoring Board (DSMB) in clinical trials?
To oversee the safety of trial participants during the study
ExplanationEnsuring participant safety.
#15
What is the purpose of adverse event reporting in clinical trials?
To document and evaluate unexpected or harmful events
ExplanationDocumenting unexpected events.
#16
Which of the following statements is true regarding the placebo effect in clinical trials?
It occurs when participants experience benefits due to their beliefs about the treatment, not the treatment itself
ExplanationBenefit from belief, not treatment.
#17
Which of the following is NOT a component of Good Clinical Practice (GCP) guidelines?
Data manipulation
ExplanationData manipulation is not part of GCP.