Human Subject Protections in Clinical Research
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Questions and Answers

What is the purpose of the IRB approval in the protocol?

  • To review and approve each study before allowing initiation of those studies (correct)
  • To ensure the correct dose of the investigational drug is administered
  • To determine the route of administration of the investigational drug
  • To describe the characteristics of patients eligible for enrollment in the trial
  • What documentation is required as part of the IND application process?

  • Documentation of IRB approval
  • Description of the dose determination
  • Details of the clinical procedures
  • None of the above (correct)
  • What is reviewed and approved by the IRB before initiating the studies?

  • The dose determination
  • The patient selection
  • The study design
  • Each study in the proposed clinical investigation (correct)
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