#1
Which organization regulates the management of investigational agents in clinical trials?
FDA
ExplanationFDA regulates investigational agents.
#2
What is the primary purpose of Investigational New Drug (IND) application?
To begin human clinical trials
ExplanationIND application initiates human trials.
#3
What is the primary purpose of the Informed Consent process in clinical trials?
To ensure participants understand the potential risks and benefits of participation
ExplanationInformed Consent clarifies risks and benefits.
#4
Which phase of clinical trials primarily focuses on assessing the safety and dosage of the investigational agent?
Phase 1
ExplanationPhase 1 assesses safety and dosage.
#5
What is the significance of Good Clinical Practice (GCP) guidelines in managing investigational agents?
To ensure the safety and welfare of participants
ExplanationGCP guidelines ensure participant safety.
#6
What are the key responsibilities of the Principal Investigator (PI) in managing investigational agents?
Regulatory compliance
ExplanationPI ensures regulatory compliance.
#7
What is the purpose of randomization in clinical trials?
To eliminate bias and ensure the validity of results
ExplanationRandomization removes bias for valid results.
#8
What does the term 'blinding' refer to in a clinical trial?
The concealment of treatment allocation from participants and/or investigators
ExplanationBlinding hides treatment allocation.
#9
Which type of clinical trial is characterized by comparing the investigational agent with a standard treatment or placebo?
Parallel-group trial
ExplanationParallel-group trial compares treatments.
#10
Which phase of clinical trials typically involves the largest number of participants?
Phase 3
ExplanationPhase 3 has the most participants.
#11
What is the purpose of the Data Safety Monitoring Board (DSMB) in clinical trials?
To ensure participant safety
ExplanationDSMB ensures participant safety.
#12
What is the primary objective of Phase 4 clinical trials?
To assess the long-term safety and efficacy of the investigational agent
ExplanationPhase 4 assesses long-term safety and efficacy.
#13
In a clinical trial, what is the primary role of a Data Safety Monitoring Board (DSMB)?
To ensure participant safety and review trial data
ExplanationDSMB ensures safety and reviews data.