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Questions and Answers
What is the purpose of the IRB approval in the protocol?
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?
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?
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)
